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U.S. Department of Health and Human Services

Enforcement Report - Week of January 15, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA Lots 6504705, 6504706 exp. 05/14 Class III Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots omits the work "not" in that sentence. Mutual Pharmaceutical Company, Inc.
Drugs Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07 Lot 6561703, exp. 03/14 Class III The reason for this recall is an error in section 5.11 of the labeling that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots omits the work "not" in that sentence. Mutual Pharmaceutical Company, Inc.
Drugs Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA lot 6581105 & 6581106 exp. 07/15, and lot 6623001 & 6623002 exp. 01/16 Class III Labeling: Incorrect Instructions: The product is being recalled due to a labeling error which provides incorrect medical advice. Mutual Pharmaceutical Company, Inc.
Food Creole & Company Creole Bisque, NET WEIGHT 3.47 oz (98g), manufacture for: Creole & Company, 145 Robert E. Lee Blvd. Penthouse Suite, New Orleans, LA 70124, UPC: 811773014869 None, the product is not lot coded Class I Product which contains milk, soy, and wheat was distributed without an ingredient statement which declares their presence. Creole & Company, LLC
Devices HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. Catalog number DF105A (Siemens Material Number 10483822) - Lot numbers GA3099, exp. 4/9/13; GA3141, exp. 5/21/13; GA3197, exp. 7/16/13; GA3247, exp. 9/4/13; GA3113, exp. 4/23/13; GA3162, exp. 6/11/13; GB3211, exp. 7/30/13; GA3267, exp. 9/24/13; GA3134, exp. 5/14/13; GA3169, exp. 6/18/13; GA3232, exp. 8/20/13; GB3281, exp. 10/8/13, GC3302, exp. 10/29/13. Class II Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed. Siemens Healthcare Diagnostics, Inc.
Devices HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. Catalog number K3105A (Siemens Material Number 10470481) - Lot numbers 12072AA, exp. 2/9/13: 12086AA, exp. 2/23/13:12107AA, exp. 3/16/13; 12128AA, exp. 4/6/13; 12150AA, exp. 4/28/13; 12191AA, exp. 6/8/13; 12212AA, exp. 6/29/13; 12226AA, exp. 7/13/13; 12248AA, exp. 8/4/13; 12261AA, exp. 8/17/13; 12282AA, exp. 9/7/13; 12303AA, exp. 9/28/13. Class II Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed. Siemens Healthcare Diagnostics, Inc.
Devices Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number Serial numbers NS 10324 through NS 10392 Class II TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE OEC 9800/9900 and Philips FDS and FDB Cath Labs due to potential safety issue related to the use of this product producing uncommanded X-ray. Trans American Medical, Inc.
Devices PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. Lot: 012212-001 Class II Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. SpineFrontier, Inc.
Devices ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Intended for cutting and shaping bone. Serial Number 31496602 Class II The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use.. The Anspach Effort, Inc.
Devices ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126** Intended for cutting and shaping bone. Serial Number G11307654403 Class II The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use.. The Anspach Effort, Inc.
Devices ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Intended for cutting and shaping bone. Serial Number MM900 Class II The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use.. The Anspach Effort, Inc.
Devices ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Intended for cutting and shaping bone. Serial Number F37306977201 Class II The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use.. The Anspach Effort, Inc.
Devices Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood. All serial numbers Class II Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage Nova Biomedical Corporation
Food Terrain Zyme Myco-Zyme (Z-13), Enzyme-Based Herbal Dietary Supplement, packaged as 90 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606. Lot # 130401 Class II Innovative Labs, LLC. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent. Innovative Labs, LLC
Food Terrain Zyme LGS-Zyme (Z-12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, packaged as 120 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606. Lot # 130444 Class II Innovative Labs, LLC. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent. Innovative Labs, LLC
Drugs Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. All Lots Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Compounding Centre At Blue Ridge
Drugs PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. All Lots Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Compounding Centre At Blue Ridge
Drugs Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. All Lots Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Compounding Centre At Blue Ridge
Drugs Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. All Lots Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Compounding Centre At Blue Ridge
Drugs Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. All Lots Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Compounding Centre At Blue Ridge
Devices The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use - Ceph upgradeable for expanded extraoral exam capabilities - The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire, IL 60069; 847-415-9800 Toll-free 888-924-3800 Vantage Panoramic X-Ray System firmware versions: 3.0, 3.1, 3.2, and 3.3. Vantage Panoramic X-Ray System Catalog Numbers and Serial Numbers: Catalog Number V5000, Serial Numbers ZM81025, ZM81026, ZM81030, ZZ08005, ZZ08006, ZZ08007, ZZ08008, ZZ08009, ZZ08010, ZZ08011, ZZ08012, ZZ08013, ZZ08015, ZZ08016, ZZ08017, Z08018, ZZ08019, ZZ08020, ZZ08021, ZZ08022, ZZ08023, ZB51001, ZB51002, ZB51006, ZB51007, ZT18018, ZY49014, ZK58019, ZS54011, ZP01043, ZV78016, ZE09006, ZN44018, ZS59007, ZS59001, ZW15007, ZW34003, ZW34012, ZW34018, ZY49012, ZY49015, ZZ02010, ZM81022, ZS54012, ZE09019, ZM81017, ZT18004, ZT18015, ZN44020, ZE09012, ZM81023, ZT27012; Catalog Number V5050, Serial Number ZZ08014; Catalog Number V5100, Serial Numbers ZM81027, ZM81028, ZZ08003; Catalog Number V5150, Serial Number ZZ08002; Catalog Number V5150C, Serial Number ZM81016 Class II An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control button (i.e. failure to stop"). Midmark Corp dba Progeny Inc
Devices Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K~home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. All serial numbers Class II 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup Fresenius Medical Care Holdings, Inc.
Devices Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. DRX Revolution Mobile X-Ray Systems manufactured from June 2012 through October 2013: Serial Numbers DRXR00690, 111, 114, 119, 121, 122, 123, 125, 126, 134, 142, 143, 151, 152, 153, 154, 155, 161, 162, 163, 164, 165, 166, 167, 168, 169, 173, 174, 176, 177, 178, 180, 181, 182, 183, 188, 189, 190, 191, 192, 196, 197, 198, 199, 201, 202, 203, 205, 206, 207, 208, 209, 211, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 254, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 275, 276, 279, 280, 281, 282, 283, 284, 285, 286, 305, 312, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 330, 331, 332, 333, 334, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 353, 355, 357, 358, 359, 360, 361, 362, 363, 364, 365, 372, 373, 375, 376, 379, 380, 381, 382, 383, 384, 385, 386, 388, 394, 395, 396, 397, 398, 399, 400, 401, 403, 405, 412, 413, 414, 415, 417, 420, 421, 423, 431, 432, 433, 434, 435, 441, 442, 443, 444, 451, 452, 454, 455, 456, 457, 458, 459, 460, 461, 464, 466, 467, 487, 488, 489, 490, 495, 506, 510, 511, 512, 514, 515, 516, 517, 518, 519, 520, 521, 522, 523, 524, 530, 538, 541, 542, 543, 544, 545, 546, 547, 548, 549, 555, 557, 560, 561, 562, 563, 564, 581, 583, 584, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599, 601, 602, 603, 609, 610, 611, 612, 613, 614, 616, 619, 620, 621, 622, 626, 627, 628, 629, 631, 632, 633, 634, 635, 636, 637, 639, 644, 645, 649, 650, 651, 656, 657, 658, 659, 660, 661, 663, 664, 665, 676, 677, 682, 685, 686, 687, 688, 689, 691, 692, 694, 696, 697, 698, 699, 700, 702, 703, 704, 705, 706, 707, 718, 723, 724. Class II It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system. Carestream Health Inc.
Devices EOS System X- ray beam Digital radiography system used in general radiographic examinations. EOS System Class II EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition. EOS Imaging
Devices Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert" Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody. Lot/Unit Codes: DSD-765-011 (Alere PN 4012350099)  DOA2100709, DOA2110198, DOA2120093, DOA3010031, DOA3010095, DOA3010096, DOA3010393, DOA3010566, DOA3020420. DSD-765-011 (Alere PN 4080350099)  DOA2100672, DOA2120094, DOA2120095, DOA2120158, DOA3010013, DOA3010064, DOA3010097, DOA3010394, DOA3010565, DOA3020557. DSF-765-031 (Alere PN 4584150099)  DOA2100438, DOA2100667, DOA2110073, DOA2110315, DOA2120096, DOA2120738, DOA2120739, DOA3010003, DOA3010004, DOA3010005, DOA3010199, DOA3010202, DOA3020182, DOA3020183. DSF-765-011 (Alere PN 4582290164)  DOA2100250, DOA2110316 , DOA2110317 , DOA2120502, DOA2120503, DOA3010236. DSF-765-011 (Alere PN 4028220211)  DOA2100614. Expiration date, or Expected shelf life: 10/31/14 to 2/28/15. Expected shelf life: 24 months. Class II Alere initiated this recall of certain lots of the Oral Fluid Drug Scrren Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk. Alere San Diego, Inc.
Food Armanino Alfredo Sauce; Frozen in 10 oz x 12 pouches per case (sample, not for retail sale) and 3 lb. pouches 4 x 3 lb. pouches per case for food service use UPC - 10 oz. samples: 10041622 002635 UPC 3 lb. pouch: 10041622 019428 Distributed by Armanino Foods, Hayward, CA; Manufactured by Del Monaco Specialty Foods, Walnut Creek, CA Three lots of the 10 oz. pacakges, and 2 lots of the 3 lb. packages are under recall. The codes for these are as follows: 10 oz. sample size: Product code: 41622 263AS: DSF Code: 960110 Package code: A26713, Packaging Date: 09/24/13 Case code: 0924139438; Package code: A26913 Packaging Date: 09/26/13 Case code: 0926139569; Package code: A31113 Packaging Date: 11/07/13 Case code: 1107131625 4 x 3 lb. pouch size: Product code 41622-1942F; DSF Code 941270 Package code: Use by 9-25-14 Packaging Date:9/25/13 Case code:0925139543 Package code: Use by 11/06/14 Packaging Date: 11/06/13 Case code: 1106131577 Class II The product was not labeled with ingredients nor with an allergen declaration; the carton only contained one label which states the product identity by the second label with ingredients and allergen information was inadvertently left off. The product is for food service and is sold in cartons of 4 x 3 lb. individual pouches and samples, not for retail sales. Del Monaco Specialty Foods Inc.
Devices The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network. SERIAL NUMBERS OF DEVICES DISTRIBUTED IN THE US: KA008788, KA009581, KA009685, KA009776, KA009917, KA010079, KA010193, KA010996, KA011141, KA011192, KA011227, KA011228, KA011231, KA011249, KA011303, KA011307, KA011311, KA011314, KA011327, KA011355, KA011356, KA011609, KA011610, KA011611, KA011667, KA011671, KA011672, KA011673, KA011674, KA011675, KA011676, KA011677, KA011678, KA011682, KA011731, KA011758, KA020006, KA020007, KA020008, KA020009, KA020010, KA020011, KA020012, KA020013, KA020014, KA020015, KA020016, KA020018, KA020023, KA020088, KA020091, KA020092, KA020093, KA020116, KA020135, KA020140, KA020149, KA020150, KA020151, KA020192, KA020200, KA020206, KA020207, KA020208, KA020209, KA020210, KA020211, KA020212, KA020213, KA020214, KA020215, KA020262, KA020264, KA020265, KA020266, KA020269, KA020270, KA020273, KA020295, KA020299, KA020304, KA020310, KA020311, KA020313, KA020314, KA020321, KA020381, KA020385, KA020386, KA020387, KA020388, KA020389, KA020390, KA020391, KA020392, KA020393, KA020394, KA020405, KA020406, KA020407, KA020408, KA020409, KA020410, KA020411, KA020412, KA020413, KA020414, KA020417, KA020422, KA020423, KA020424, KA020425, KA020426, KA020427, KA020429, KA020430, KA020432, KA020433, KA020435, KA020436, KA020437, KA020438, KA020439, KA020442, KA020443, KA020444, KA020445, KA020446, KA020447, KA020448, KA020449, KA020450, KA020451, KA020452, KA020453, KA020454, KA020455, KA020456, KA020457, KA020458, KA020459, KA020460, KA020461, KA020462, KA020463, KA020464, KA020465, KA020466, KA020467, KA020468, KA020469, KA020470, KA020471, KA020472, KA020473, KA020474, KA020475, KA020477, KA020478, KA020479, KA020480, KA020481, KA020482, KA020483, KA020526, KA020529, KA020532, KA020533, KA020534, KA020535, KA020536, KA020537, KA020538, KA020540, KA020541, KA020542, KA020543, KA020545, KA020546, KA020547, KA020548, KA020549, KA020550, KA020551, KA020552, KA020553, KA020554, KA020555, KA020556, KA020557, KA020558, KA020559, KA020560, KA020561, KA020562, KA020563, KA020564, KA020575, KA020576, KA020577, KA020578, KA020581, KA020582, KA020595, KA020596, KA020597, KA020606, KA020611, KA020613, KA020617, KA020631, KA020632, KA020633, KA020641, KA020646, KA020649, KA020650, KA020655, KA020659, KA020666, KA020685, KA020691, KA020692, KA020693, KA020726, KA020729, KA020742, KA020743, KA020746, KA020748, KA020853, KA020908, KA020909, KA020916, KA020917, KA021019, KA021028, KA021043, KA021048, KA021061, KA021062, KA021063, KA021064, KA021065, KA021086, KA021126, KA021151, KA021155, KA021158, KA021159, KA021170, KA021181, KA021182, KA021184, KA021188, KA021190, KA021202, KA021221, KA021277, KA021278, KA021279, KA021280, KA021286, KA021294, KA021298, KA021299, KA021311, KA021312, KA021313, KA021318, KA021319, KA021322, KA021323, KA021327, KA021330, KA021349, KA021365, KA021366, KA021367, KA021368, KA021369, KA021370, KA021371, KA021392, KA021393, KA021394, KA021395, KA021396, KA021397, KA021398, KA021399, KA021401, KA021402, KA021403, KA021406, 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KA024625, KA024626, KA024627, KA024628, KA024629, KA024662, KA024666, KA024668, KA024798, KA024801, KA024804, KA024807, KA024809, KA024811, KA024813, KA024814, KA024817, KA024822, KA024870, KA024871, KA024873, KA024900, KA024902, KA024908, KA024915, KA024919, KA024921, KA024922, KA024943, KA024944, KA024945, KA024946, KA024947, KA024948, KA024949, KA024950, KA024951, KA024992, KA024997, KA024998, KA024999, KA025001, KA025003, KA025004, KA025010, KA025011, KA025012, KA025013, KA025016, KA025031, KA025035, KA025041, KA025043, KA025053, KA025062, KA025064, KA025089, KA025090, KA025092, KA025093, KA025095, KA025096, KA025126, KA025144, KA025145, KA025159, KA025160, KA025168, KA025177, KA025180, KA025181, KA025182, KA025183, KA025184, KA025185, KA025186, KA025191, KA025203, KA025204, KA025205, KA025226, KA025229, KA025230, KA025231, KA025232, KA025233, KA025235, KA025236, KA025238, KA025239, KA025240, KA025241, KA025262, KA025263, KA025264, KA025265, KA025266, KA025267, KA025268, KA025269, KA025272, KA025275, KA025280, KA025282, KA025296, KA025302, KA025304, KA025305, KA025306, KA025307, KA025308, KA025309, KA025310, KA025311, KA025312, KA025313, KA025314, KA025315, KA025316, KA025317, KA025318, KA025319, KA025320, KA025321, KA025322, KA025323, KA025325, KA025326, KA025327, KA025330, KA025355, KA025428, KA025433, KA025434, KA025435, KA025436, KA025437, KA025448, KA025510, KA025524, KA025535, KA025578, KA025579, KA025580, KA025581, KA025614, KA025615, KA025616, KA025617, KA025629, KA025733, KA025734, KA025735, KA025736, KA025737, KA025740, KA025875, KA025876, KA025877, KA025879, KA025891, KA025892, KA025898, KA025902, KA025903, KA025908, KA025909, KA025910, KA025911, KA025912, KA025938, KA025939, KA026024, KA026028, KA026029, KA026041, KA026042, KA026045, KA026046, KA026048, KA026049, KA026050, KA026052, KA026053, KA026054, KA026056, KA026057, KA026058, KA026059, KA026062, KA026063, KA026105, KA026107, KA026108, KA026110, KA026111, KA026140, KA026141, KA026142, KA026143, KA026151, KA026152, KA026154, KA026157, KA026178, KA026179, KA026180, KA026181, KA026182, KA026184, KA026263, KA026264, KA026265, KA026278, KA026287, KA026288, KA026302, KA026370, KA026371, KA026372, KA026373, KA026375, KA026376, KA026377, KA026378, KA026379, KA026406, KA026407, KA026408, KA026409, KA026410, KA026412, KA026416, KA026457, KA026499, KA026502, KA026503, KA026504, KA026505, KA026506, KA026507, KA026508, KA026509, KA026573, KA026574, KA026575, KA026576, KA026638, KA026639, KA026751, KA026752, KA026753, KA026763, KA026766, KA026771, KA026774, KA026797, KA026815, KA026816, KA026817, KA026818, KA026819, KA026820, KA026821, KA026822, KA026823, KA026824, KA026825, KA026826, KA026838, KA026849, KA026854, KA026856, KA026857, KA026869, KA026872, KA026933, KA026938, KA026939, KA026941, KA026942, KA026944, KA026945, KA026946, KA026948, KA026950, KA026951, KA026952, KA026953, KA026954, KA026955, KA026956, KA026957, KA026958, KA026959, KA026960, KA026961, KA026962, KA026963, KA026964, KA026985, KA026987, KA026992, KA027029, KA027031, KA027032, KA027033, KA027045, KA027130, KA027134, KA027135, KA027136, KA027137, KA027138, KA027147, KA027148, KA027157, KA21398, KA21399, and KA21407. SERIAL NUMBERS OF DEVICES DISTRIBUTED OUTSIDE THE US: KA002129, KA002130, KA008395, KA008397, KA008401, KA008600, KA008715, KA008794, KA009204, KA009205, KA009208, KA009212, KA009260, KA009268, KA009350, KA009393, KA009394, KA009395, KA009396, KA009397, KA009399, KA009400, KA009402, KA009404, KA009406, KA009407, KA009408, KA009429, KA009438, KA009446, KA009449, KA009451, KA009452, KA009457, KA009458, KA009470, KA009504, KA009572, KA009575, KA009578, KA009579, KA009587, KA009611, KA009665, KA009666, KA009667, KA009668, KA009669, KA009671, KA009672, KA009675, KA009677, KA009690, KA009693, KA009699, KA009707, KA009708, KA009755, KA009796, KA009822, KA009826, KA009827, KA009829, KA009896, KA009897, KA009913, KA009946, KA010203, KA010362, KA010366, KA010370, KA010448, KA010496, KA010548, KA010596, KA010753, KA010787, KA010788, KA010795, KA010835, KA010836, KA010922, KA010923, KA011029, KA011071, KA011075, KA011095, KA011120, KA011150, KA011161, KA011186, KA011189, KA011209, KA011210, KA011211, KA011212, KA011215, KA011218, KA011229, KA011232, KA011263, KA011276, KA011283, KA011394, KA011396, KA011397, KA011399, KA011401, KA011402, KA011403, KA011404, KA011405, KA011409, KA011410, KA011411, KA011412, KA011413, KA011414, KA011416, KA011417, KA011418, KA011419, KA011420, KA011422, KA011423, KA011424, KA011425, KA011426, KA011427, KA011428, KA011430, KA011431, KA011432, KA011433, KA011434, KA011435, KA011436, KA011437, KA011438, KA011439, KA011440, KA011448, KA011449, KA011452, KA011463, KA011467, KA011468, KA011469, KA011470, KA011471, KA011472, KA011473, KA011474, KA011475, KA011476, KA011478, KA011479, KA011480, KA011481, KA011482, KA011483, KA011484, KA011485, KA011488, KA011489, KA011490, KA011491, KA011492, KA011493, KA011494, KA011495, KA011496, KA011497, KA011498, KA011500, KA011501, KA011502, KA011503, KA011504, KA011506, KA011507, KA011508, KA011514, KA011571, KA011573, KA011575, KA011576, KA011580, KA011581, KA011582, KA011583, KA011585, KA011586, KA011587, KA011588, KA011589, KA011596, KA011625, KA011640, KA011641, KA011642, KA011643, KA011654, KA011655, KA011657, KA011658, KA011659, KA011660, KA011661, KA011662, KA011663, KA011664, KA011665, KA011666, KA011668, KA011669, KA011670, KA011680, KA011683, KA011703, KA011704, KA011730, KA011735, KA011737, KA011738, KA011741, KA011742, KA011743, KA011745, KA011746, KA011754, KA011755, KA011756, KA011757, KA011760, KA011761, KA011763, KA011765, KA011766, KA011767, KA011768, KA011771, KA011793, KA020017, KA020019, KA020020, KA020021, KA020022, KA020024, KA020025, KA020086, KA020087, KA020089, KA020090, KA020094, KA020095, KA020114, KA020115, KA020117, KA020118, KA020119, KA020120, KA020121, KA020122, KA020123, KA020124, KA020125, KA020126, KA020127, KA020128, KA020129, KA020130, KA020131, KA020132, KA020133, KA020134, KA020136, KA020137, KA020138, KA020139, KA020141, KA020142, KA020143, KA020144, KA020145, KA020146, KA020147, KA020148, KA020152, KA020153, KA020189, KA020190, KA020191, KA020193, KA020196, KA020197, KA020198, KA020199, KA020201, KA020202, KA020203, KA020204, KA020205, KA020231, KA020256, KA020257, KA020258, KA020259, KA020260, KA020261, KA020263, KA020267, KA020268, KA020271, KA020272, KA020274, KA020275, KA020286, KA020287, KA020288, KA020289, KA020290, KA020291, KA020292, KA020293, KA020294, KA020296, KA020297, KA020298, KA020300, KA020301, KA020302, KA020303, KA020305, KA020306, KA020307, KA020308, KA020309, KA020312, KA020315, KA020316, KA020317, KA020318, KA020319, KA020320, KA020322, KA020323, KA020324, KA020325, KA020326, KA020349, KA020350, KA020351, KA020352, KA020353, KA020354, KA020355, KA020356, KA020357, KA020358, KA020373, KA020374, KA020375, KA020376, KA020377, KA020378, KA020379, KA020380, KA020382, KA020383, KA020384, KA020400, KA020401, KA020402, KA020403, KA020404, KA020415, KA020416, KA020418, KA020419, KA020420, KA020421, KA020428, KA020431, KA020434, KA020440, KA020441, KA020476, KA020484, KA020525, KA020527, KA020528, KA020530, KA020531, KA020539, KA020544, KA020579, KA020580, KA020583, KA020584, KA020585, KA020586, KA020587, KA020588, KA020589, KA020590, KA020591, KA020592, KA020593, KA020594, KA020598, KA020599, KA020600, KA020601, KA020602, KA020603, KA020604, KA020605, KA020607, KA020608, KA020609, KA020610, KA020612, KA020614, KA020615, KA020616, KA020618, KA020619, KA020630, KA020634, KA020635, KA020636, KA020637, KA020638, KA020639, KA020640, KA020642, KA020643, KA020644, KA020645, KA020647, KA020648, KA020651, KA020652, KA020653, KA020654, KA020656, KA020657, KA020658, KA020660, KA020661, KA020662, KA020663, KA020664, KA020665, KA020667, KA020668, KA020669, KA020680, KA020681, KA020682, KA020683, KA020684, KA020686, KA020687, KA020688, KA020689, KA020690, KA020694, KA020700, KA020701, KA020702, KA020703, KA020704, KA020705, KA020706, KA020707, KA020708, KA020709, KA020710, KA020711, KA020712, KA020713, KA020714, KA020715, KA020716, KA020717, KA020718, KA020719, KA020720, KA020721, KA020722, KA020723, KA020724, KA020725, KA020727, KA020728, KA020730, KA020731, KA020732, KA020733, KA020734, KA020735, KA020736, KA020737, KA020738, KA020739, KA020740, KA020741, KA020744, KA020745, KA020747, KA020749, KA020750, KA020751, KA020752, KA020753, KA020754, KA020755, KA020756, KA020757, KA020758, KA020759, KA020781, KA020782, KA020783, KA020784, KA020785, KA020786, KA020787, KA020788, KA020789, KA020790, KA020791, KA020792, KA020793, KA020794, KA020795, KA020796, KA020797, KA020798, KA020799, KA020800, KA020801, KA020802, KA020803, KA020804, KA020805, KA020806, KA020807, KA020808, KA020809, KA020810, KA020811, KA020812, KA020813, KA020814, KA020815, KA020816, KA020817, KA020818, KA020819, KA020820, KA020821, KA020822, KA020823, KA020824, KA020825, KA020826, KA020827, KA020828, KA020829, KA020830, KA020831, KA020832, KA020833, KA020834, KA020835, KA020836, KA020837, KA020838, KA020839, KA020840, KA020841, KA020842, KA020843, KA020844, KA020845, KA020846, KA020847, KA020848, KA020849, KA020850, KA020851, KA020852, KA020854, KA020855, KA020856, KA020857, KA020858, KA020859, KA020860, KA020861, KA020862, KA020863, KA020864, KA020865, KA020866, KA020867, KA020868, KA020869, KA020870, KA020871, KA020872, KA020873, KA020874, KA020875, KA020876, KA020877, KA020878, KA020879, KA020880, KA020881, KA020882, KA020883, KA020884, KA020885, KA020886, KA020887, KA020888, KA020889, KA020890, KA020891, KA020892, KA020893, KA020894, KA020895, KA020896, KA020897, KA020898, KA020899, KA020900, KA020901, KA020902, KA020903, KA020904, KA020905, KA020906, KA020907, KA020910, KA020911, KA020912, KA020913, KA020914, KA020915, KA020918, KA020919, KA020920, KA020921, KA020922, KA020923, KA020924, KA020925, KA020926, KA020927, KA020928, KA020929, KA020930, KA020931, KA020932, KA020933, KA020934, KA020935, KA020936, KA020937, KA020938, KA020939, KA020940, KA020941, KA020942, KA020943, KA020944, KA020945, KA020946, KA020947, KA020948, KA020949, KA020950, KA020951, KA020952, KA020953, KA020954, KA020955, KA020956, KA020957, KA020958, KA020959, KA020960, KA020961, KA020962, KA020963, KA020964, KA020965, KA020966, KA020967, KA020968, KA020969, KA020970, KA020971, KA020972, KA020973, KA020974, KA020975, KA020976, KA020977, KA020978, KA020979, KA020980, KA020981, KA020982, KA020983, KA020984, KA020985, KA020986, KA020987, KA020988, KA020989, KA020990, KA020991, KA020992, KA020993, KA020994, KA020995, KA020996, KA020997, KA020998, KA020999, KA021000, KA021001, KA021002, KA021003, KA021004, KA021005, KA021006, KA021007, KA021008, KA021009, KA021010, KA021011, KA021012, KA021013, KA021014, KA021015, KA021016, KA021017, KA021018, KA021020, KA021021, KA021022, KA021023, KA021024, KA021025, KA021026, KA021027, KA021029, KA021030, KA021031, KA021032, KA021033, KA021034, KA021035, KA021036, KA021037, KA021038, KA021039, KA021040, KA021041, KA021042, KA021044, KA021045, KA021046, KA021047, KA021049, KA021050, KA021051, KA021052, KA021053, KA021054, KA021055, KA021056, KA021057, KA021058, KA021059, KA021060, KA021087, KA021088, KA021089, KA021090, KA021091, KA021092, KA021093, KA021094, KA021095, KA021096, KA021097, KA021098, KA021099, KA021100, KA021101, KA021102, KA021103, KA021104, KA021105, KA021106, KA021107, KA021108, KA021109, KA021110, KA021111, KA021112, KA021113, KA021114, KA021115, KA021116, KA021117, KA021118, KA021119, KA021120, KA021121, KA021122, KA021123, KA021124, KA021125, KA021127, KA021128, KA021129, KA021130, KA021131, KA021132, KA021133, KA021134, KA021135, KA021136, KA021137, KA021138, KA021139, KA021140, KA021141, KA021142, KA021143, KA021144, KA021145, KA021146, KA021147, KA021148, KA021149, KA021150, KA021152, KA021153, KA021154, KA021156, KA021157, KA021160, KA021161, KA021162, KA021163, KA021164, KA021165, KA021166, KA021167, KA021168, KA021169, KA021171, KA021172, KA021173, KA021174, KA021175, KA021176, KA021177, KA021178, KA021179, KA021180, KA021183, KA021185, KA021186, KA021187, KA021189, KA021191, KA021192, KA021193, KA021194, KA021195, KA021196, KA021197, KA021198, KA021199, KA021200, KA021201, KA021203, KA021204, KA021205, KA021206, KA021207, KA021208, KA021209, KA021210, KA021211, KA021212, KA021213, KA021214, KA021215, KA021216, KA021217, KA021218, KA021219, KA021220, KA021222, KA021223, KA021224, KA021225, KA021226, KA021227, KA021228, KA021229, KA021230, KA021231, KA021232, KA021233, KA021234, KA021235, KA021236, KA021237, KA021238, KA021239, KA021240, KA021241, KA021242, KA021243, KA021244, KA021245, KA021246, KA021247, KA021248, KA021249, KA021250, KA021251, KA021252, KA021253, KA021254, KA021255, KA021256, KA021257, KA021258, KA021259, KA021260, KA021261, KA021262, KA021263, KA021264, KA021265, KA021266, KA021281, KA021282, KA021283, KA021284, KA021285, KA021287, KA021288, KA021289, KA021290, KA021291, KA021292, KA021293, KA021295, KA021296, KA021297, KA021300, KA021301, KA021302, KA021303, KA021304, KA021305, KA021306, KA021307, KA021308, KA021309, KA021310, KA021314, KA021315, KA021316, KA021317, KA021320, KA021321, KA021324, KA021325, KA021326, KA021328, KA021329, KA021331, KA021332, KA021333, KA021334, KA021335, KA021336, KA021337, KA021338, KA021339, KA021340, KA021341, KA021342, KA021343, KA021344, KA021345, KA021346, KA021347, KA021348, KA021350, KA021351, KA021352, KA021353, KA021354, KA021355, KA021356, KA021357, KA021358, KA021359, KA021360, KA021361, KA021362, KA021363, KA021364, KA021400, KA021404, KA021405, KA021409, KA021411, KA021412, KA021414, KA021416, KA021418, KA021420, KA021421, KA021422, KA021423, KA021424, KA021425, KA021428, KA021430, KA021431, KA021432, KA021433, KA021434, KA021435, KA021436, KA021457, KA021458, KA021459, KA021460, KA021461, KA021463, KA021464, KA021467, KA021468, KA021470, KA021471, KA021472, KA021473, KA021474, KA021475, KA021476, KA021477, KA021478, KA021479, KA021480, KA021481, KA021482, KA021483, KA021484, KA021485, KA021487, KA021488, KA021489, KA021490, KA021491, KA021493, KA021494, KA021496, KA021497, KA021498, KA021499, KA021500, KA021501, KA021502, KA021504, 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KA025626, KA025627, KA025628, KA025630, KA025631, KA025632, KA025633, KA025634, KA025635, KA025636, KA025637, KA025638, KA025639, KA025640, KA025641, KA025642, KA025643, KA025644, KA025645, KA025646, KA025647, KA025648, KA025649, KA025650, KA025651, KA025652, KA025653, KA025654, KA025655, KA025656, KA025657, KA025658, KA025659, KA025660, KA025661, KA025662, KA025663, KA025664, KA025665, KA025666, KA025667, KA025668, KA025669, KA025670, KA025671, KA025672, KA025673, KA025674, KA025675, KA025676, KA025677, KA025678, KA025679, KA025680, KA025681, KA025682, KA025683, KA025684, KA025685, KA025686, KA025687, KA025688, KA025689, KA025690, KA025691, KA025692, KA025718, KA025719, KA025720, KA025721, KA025722, KA025723, KA025724, KA025725, KA025726, KA025727, KA025728, KA025729, KA025730, KA025731, KA025732, KA025739, KA025741, KA025742, KA025743, KA025744, KA025745, KA025746, KA025747, KA025748, KA025749, KA025750, KA025751, KA025752, KA025753, KA025754, KA025755, KA025756, KA025757, KA025758, KA025759, KA025760, KA025761, KA025762, KA025771, KA025772, KA025773, KA025774, KA025775, KA025776, KA025777, KA025778, KA025779, KA025780, KA025781, KA025782, KA025783, KA025784, KA025785, KA025786, KA025787, KA025788, KA025789, KA025790, KA025791, KA025792, KA025793, KA025794, KA025795, KA025796, KA025797, KA025798, KA025799, KA025800, KA025801, KA025802, KA025803, KA025804, KA025805, KA025806, KA025807, KA025808, KA025809, KA025810, KA025811, KA025812, KA025813, KA025814, KA025815, KA025816, KA025817, KA025818, KA025819, KA025820, KA025821, KA025822, KA025823, KA025824, KA025825, KA025826, KA025827, KA025828, KA025829, KA025830, KA025841, KA025842, KA025843, KA025844, KA025845, KA025846, KA025847, KA025848, KA025849, KA025850, KA025851, KA025852, KA025853, KA025854, KA025855, KA025856, KA025857, KA025858, KA025859, KA025860, KA025861, KA025862, KA025863, KA025864, KA025865, KA025866, KA025867, KA025868, KA025869, KA025870, KA025871, KA025872, KA025873, KA025874, KA025878, KA025880, KA025881, KA025882, KA025883, KA025884, KA025885, KA025886, KA025887, KA025888, KA025889, KA025890, KA025893, KA025894, KA025895, KA025896, KA025897, KA025899, KA025900, KA025901, KA025904, KA025905, KA025906, KA025907, KA025913, KA025914, KA025915, KA025916, KA025917, KA025918, KA025919, KA025920, KA025921, KA025922, KA025923, KA025924, KA025925, KA025926, KA025928, KA025929, KA025930, KA025932, KA025935, KA025936, KA025937, KA025941, KA025942, KA025943, KA025944, KA025945, KA025946, KA025947, KA025948, KA025949, KA025950, KA025979, KA025980, KA025981, KA025982, KA025983, KA025984, KA025985, KA025986, KA025987, KA025988, KA025989, KA025990, KA025991, KA025992, KA025993, KA025994, KA025995, KA025996, KA025997, KA025998, KA025999, KA026000, KA026001, KA026002, KA026003, KA026004, KA026005, KA026006, KA026007, KA026008, KA026009, KA026010, KA026011, KA026012, KA026013, KA026014, KA026015, KA026016, KA026017, KA026018, KA026019, KA026020, KA026021, KA026022, KA026023, KA026025, KA026026, KA026027, KA026030, KA026031, KA026032, KA026033, KA026034, KA026035, KA026036, KA026037, KA026038, KA026039, KA026040, KA026043, KA026044, KA026047, KA026051, KA026055, KA026060, KA026061, KA026064, KA026092, KA026093, KA026094, KA026095, KA026096, KA026097, KA026098, KA026099, KA026100, KA026102, KA026103, KA026104, KA026106, KA026109, KA026112, KA026113, KA026114, KA026115, KA026116, KA026117, KA026118, KA026119, KA026131, KA026134, KA026135, KA026136, KA026137, KA026138, KA026139, KA026144, KA026145, KA026146, KA026147, KA026148, KA026149, KA026150, KA026153, KA026155, KA026156, KA026158, KA026159, KA026160, KA026161, KA026162, KA026163, KA026164, KA026166, KA026167, KA026168, KA026169, KA026170, KA026171, KA026172, KA026173, KA026174, KA026175, KA026176, KA026177, KA026183, KA026185, KA026186, KA026187, KA026188, KA026189, KA026190, KA026191, KA026192, KA026193, KA026194, KA026195, KA026196, KA026197, KA026198, KA026199, KA026200, KA026201, KA026202, KA026203, KA026204, KA026205, KA026206, KA026207, KA026208, KA026209, KA026210, KA026211, KA026212, KA026213, KA026214, KA026215, KA026216, KA026217, KA026218, KA026219, KA026220, KA026221, KA026222, KA026223, KA026224, KA026225, KA026226, KA026227, KA026228, KA026229, KA026230, KA026231, KA026232, KA026233, KA026234, KA026235, KA026236, KA026238, KA026239, KA026240, KA026241, KA026242, KA026243, KA026244, KA026245, KA026246, KA026247, KA026248, KA026249, KA026250, KA026251, KA026252, KA026253, KA026254, KA026255, KA026256, KA026257, KA026258, KA026259, KA026260, KA026261, KA026262, KA026266, KA026267, KA026268, KA026269, KA026270, KA026271, KA026272, KA026273, KA026274, KA026275, KA026276, KA026277, KA026279, KA026280, KA026281, KA026282, KA026284, KA026289, KA026290, KA026291, KA026292, KA026293, KA026294, KA026295, KA026296, KA026297, KA026298, KA026299, KA026300, KA026301, KA026303, KA026304, KA026305, KA026306, KA026307, KA026308, KA026309, KA026310, KA026311, KA026312, KA026313, KA026314, KA026315, KA026316, KA026317, KA026318, KA026319, KA026320, KA026321, KA026322, KA026323, KA026324, KA026325, KA026326, KA026327, KA026328, KA026329, KA026330, KA026331, KA026332, KA026333, KA026334, KA026335, KA026336, KA026337, KA026338, KA026339, KA026340, KA026341, KA026342, KA026343, KA026344, KA026345, KA026346, KA026347, KA026348, KA026349, KA026350, KA026351, KA026352, KA026353, KA026354, KA026355, KA026356, KA026357, KA026358, KA026359, KA026360, KA026361, KA026362, KA026363, KA026364, KA026366, KA026367, KA026369, KA026374, KA026381, KA026382, KA026383, KA026384, KA026385, KA026386, KA026387, KA026388, KA026389, KA026390, KA026391, KA026392, KA026393, KA026394, KA026395, KA026396, KA026397, KA026398, KA026399, KA026400, KA026401, KA026402, KA026403, KA026404, KA026405, KA026415, KA026432, KA026433, KA026434, KA026435, KA026436, KA026437, KA026438, KA026439, KA026440, KA026441, KA026442, KA026443, KA026444, KA026445, KA026446, KA026447, KA026448, KA026449, KA026450, KA026451, KA026452, KA026453, KA026456, KA026458, KA026460, KA026461, KA026462, KA026463, KA026465, KA026466, KA026468, KA026469, KA026470, KA026472, KA026475, KA026476, KA026478, KA026479, KA026481, KA026482, KA026483, KA026484, KA026485, KA026486, KA026487, KA026490, KA026491, KA026492, KA026493, KA026494, KA026495, KA026496, KA026497, KA026500, KA026510, KA026511, KA026512, KA026513, KA026518, KA026520, KA026522, KA026524, KA026525, KA026529, KA026530, KA026531, KA026533, KA026534, KA026535, KA026536, KA026537, KA026538, KA026539, KA026540, KA026541, KA026542, KA026543, KA026546, KA026547, KA026548, KA026549, KA026550, KA026551, KA026553, KA026554, KA026555, KA026556, KA026557, KA026558, KA026559, KA026560, KA026561, KA026562, KA026563, KA026564, KA026565, KA026568, KA026569, KA026570, KA026571, KA026640, KA026641, KA026642, KA026643, KA026644, KA026645, KA026646, KA026647, KA026648, KA026649, KA026650, KA026651, KA026652, KA026653, KA026654, KA026655, KA026656, KA026657, KA026658, KA026659, KA026660, KA026661, KA026662, KA026664, KA026665, KA026666, KA026667, KA026668, KA026669, KA026670, KA026671, KA026673, KA026674, KA026676, KA026677, KA026678, KA026679, KA026680, KA026682, KA026683, KA026684, KA026685, KA026686, KA026687, KA026688, KA026689, KA026730, KA026731, KA026732, KA026733, KA026734, KA026735, KA026744, KA026745, KA026746, KA026747, KA026748, KA026749, KA026750, KA026754, KA026755, KA026756, KA026757, KA026758, KA026759, KA026760, KA026761, KA026762, KA026765, KA026767, KA026768, KA026769, KA026770, KA026772, KA026773, KA026795, KA026796, KA026798, KA026799, KA026800, KA026801, KA026802, KA026803, KA026804, KA026805, KA026806, KA026807, KA026808, KA026809, KA026810, KA026811, KA026812, KA026813, KA026814, KA026827, KA026828, KA026829, KA026830, KA026831, KA026832, KA026833, KA026834, KA026835, KA026836, KA026837, KA026839, KA026840, KA026841, KA026842, KA026843, KA026844, KA026845, KA026846, KA026850, KA026851, KA026852, KA026853, KA026855, KA026864, KA026865, KA026867, KA026868, KA026870, KA026874, KA026936, KA026937, KA026940, KA026943, KA026949, KA026984, KA026986, KA026988, KA026989, KA026990, KA026991, KA026993, KA027010, KA027011, KA027012, KA027013, KA027014, KA027015, KA027016, KA027017, KA027018, KA027019, KA027020, KA027021, KA027022, KA027028, KA027036, KA027037, KA027038, KA027040, KA027041, KA027042, KA027043, KA027044, KA027046, KA027047, KA027048, KA027049, KA027075, KA027076, KA027077, KA027079, KA027080, KA027081, KA027082, KA027083, KA027084, KA027149, KA027150, KA027151, KA027152, KA027153, KA027154, KA027155, KA027156, KA027158, KA027159, KA027160, KA027161, KA027162, KA027163, KA027164, KA027165, KA027166, KA027167, KA027168, KA027169, KA027176, KA027177, KA027178, KA027179, KA027180, KA027181, KA027182, KA027183, KA027184, KA027185, KA027189, KA027190, KA027191, KA050687, KA124186, KA21591, KA25981, KAO24372, KAO24451, KAO24482, KAO24483, KAO24665, KAO24911, KAO24961 Class II Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations. Welch Allyn Protocol, Inc
Food EstroPlus Maximum Strength Menopause Support Dietary Supplement in 28 count and 56 count blister strips under the following labels - CareOne Maximum Strength Multi Symptom Menopause Formula, 28 Caplets/Dietary Supplement; Meijer Maximum Strength Estroplus, Dietary Supplement, 28 Caplets; TopCare Maximum Strength Estroplus Dietary Supplement, 28 Caplets; Sunmark Estroplus Extra Strength, Dietary Supplement, 56 Caplets; Health Mart Pharmacy Extra Strength Estroplus, 56 Caplets Dietary Supplement; Up&Up Estroplus Dietary Supplement Maximum Strength 28 Caplets; CareOne Extra Strength Estroplus 56 Caplets/Dietary Supplement; Western Family Extra Strength Estroplus 56 Caplets, Meijer Extra Strength Estroplus Dietary Supplement 56 Caplets; Publix Extra Strength Estroplus 56 Caplets, Dietary Supplement; and TopCare Extra Strength Estroplus Dietary Supplement 56 Caplets. 3FN0981 (Exp 04/15), 3FN1338 (Exp 04/15), 3FN1116 (Exp 04/15), 3EN1050 (Exp 04/15), 3JN1230 (Exp 04/15), 3KN1691 (Exp 05/15), 3KN1207 (Exp. 05/15), 3JN1013 (05/15), 3JN1077 (Exp 05/15), 3HN1293 (Exp 05/15), 1KN1496 (Exp 05/14), 1JN1234 (Exp 05/14), 1KN1775 (Exp. 05/14), 1LN1254 (Exp 05/14), 1LN1867 (Exp 05/14), 1MN1647 (Exp 05/14), 2AN1562 (Exp 10/14), 2AN1595 (Exp 10/14), 2BN2120 (Exp 01/15), 2DN1514 (Exp 01/15), 2DN1515 (Exp 10/14), 2DN1608 (Exp 05/14), 2DN1997 (Exp 01/15), 2EN2099 (Exp. 01/15), 2FN1524 (Exp 03/15), 2FN1923 (Exp 03/15), 2FN1939 (Exp 01/15), 2GN1806 (Exp 03/15), 2HN1412 (Exp 03/15), 2HN1496 (Exp 03/15), 2JN1383 (Exp 03/15), 2MN1156 (Exp 03/15), 3AN1835 (Exp 03/15), 3BN1683 (Exp 03/15), 3DN1482 (Exp 03/15), 3FN1132 (Exp 03/15) Class II Potential presence of Chloramphenicol contamination Perrigo of SC
Devices Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures. 510 K exempt Device Listing Number D129456 Model Number 2210-N LN 0563 Jan 2016 LN 2263 Jul 2016 Class II Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. Ansell Sandel Medical Industries LLC
Devices Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures. 510 K exempt Device Listing Number D129456 Model Number 2211-N LN 2782 9/2015 LN 1413 4/2016 LN 1623 5/2016 Class II Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. Ansell Sandel Medical Industries LLC
Devices Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures. 510 K exempt Device Listing Number D129456 Model Number 2210-L 1) LN 0662 2/2015 2) LN 2052 6/2015 Class II Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. Ansell Sandel Medical Industries LLC
Devices Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures. 510 K exempt Device Listing Number D129456 Model Number 2211-L LN 2962 Class II Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. Ansell Sandel Medical Industries LLC
Devices Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures. 510 K exempt Device Listing Number D129456 Model Number 2215-N LN 1203 and 1553 Class II Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. Ansell Sandel Medical Industries LLC
Devices Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell 2215-L Weighted Safety Scalpel, #3L Handle (8.75) with #15 Blade, Yellow Shield with TIME OUT® Sleeve (S) 12 per box; 8 boxes per case (96 total scalpels) A manual surgical scalpel blade for making incisions in various general surgical procedures. 510 K exempt Device Listing Number D129456 Model Number 2215-L LN 2052 Class II Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. Ansell Sandel Medical Industries LLC
Devices Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures. 510 K exempt Device Listing Number D129456 Model Number 2220-N LN 1793 Class II Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. Ansell Sandel Medical Industries LLC
Devices Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum. 1091271, 1094671, 1104165, 1104631, 1104813, 1110404, 1120638, 1120816, 1122316, 1123940, 11311659, 1132989, 1133427 Class II Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type package were found prior to use but after the sterile package was open Integra LifeSciences Corp.
Devices Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum. 1094085, 1101479, 1101647, 1102403, 1102807, 1104174, 1110043, 1120817, 1130797, 1131331, 1131660 Class II Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type packages were found prior to use but after the sterile package was open. Integra LifeSciences Corp.
Devices Jelco Smiths Medical Hypodermic Needle-Pro® Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro® Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath. Lot Numbers: 2340530, 2344163, 2353091, 2357317, 2377316 Class II Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro® Fixed Needle Insulin Syringes Smiths Medical ASD, Inc.
Devices Jelco Smiths Medical Hypodermic Needle-Pro® Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro® Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath. Lot Number: 2357318 Class II Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro® Fixed Needle Insulin Syringes Smiths Medical ASD, Inc.
Devices Jelco Smiths Medical Hypodermic Needle-Pro® Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro® Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath. Lot Numbers: 2330832, 2336493, 2348708, 2353094, 2357319 Class II Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro® Fixed Needle Insulin Syringes Smiths Medical ASD, Inc.
Devices Jelco Smiths Medical Hypodermic Needle-Pro® Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypodermic Needle-Pro® Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath. Lot Numbers: 2356156, 2358706 Class II Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro® Fixed Needle Insulin Syringes Smiths Medical ASD, Inc.
Devices Jelco Smiths Medical Hypodermic Needle-Pro® Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro® Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath. Lot Numbers: 2358702 Class II Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro® Fixed Needle Insulin Syringes Smiths Medical ASD, Inc.
Food Safeway Kitchens In Shell Edamame; Net Wt: 48 oz. (3 lb, 1.35Kg) 12 x 3 lb bags per case: Product of China: Packed in Canada Safeway, Pleasanton, CA. Best before May 21, 2015: Packed on November 21, 2013: UPC: 0 21130 09197 3 Class III Product on hold pending FDA testing that found 0.015 ppm of the pesticide chlorafluazuron was inadvertently released to Safeway warehouses and a few retail stores. Safeway Inc
Devices REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty. Lot 094929 Class II Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. Materialise USA LLC
Devices Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE Lot 50731155 Color code Purple Class II The Color Cuff® Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may lead to an inoperable system due to incompatibility with the Smart Pump. Stryker Instruments Div. of Stryker Corporation
Food IMT Wellness Legume Digest 2.0** Dietary Supplements 120 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT; in a white 150 cc bottle with white cap 54179002, 54179003, 54179004 Class II Potential for Chloramphenicol contamination. ANAT, LLC
Food IMT Wellness Tribulus Supreme 2.0** GI & Immune Support ** Dietary Supplements 60 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT 54217002 Class II Potential for Chloramphenicol contamination. ANAT, LLC
Devices Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN® and microspeed motor systems to hold burrs which cut and shape bone. Hi-Line XXS handpiece; Part Number - GB790R , Lot Number 4504385018 4504300008 4504328565 4504685847 4804685865 Class II Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece. Aesculap, Inc.
Devices Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only Catalog #25-3011, Lot #1049402 Class II A sharp edge on the cannulated tip of the device may damage or cut a suture. ArthroCare Medical Corporation
Devices C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization. part numbers: 30-CW-1012-5, 30-CW-1012-6, 30-CW-1012-7, 30-CW-1012-8, 30-CW-1012-9, 30-CW-1 012-10, 30-CW-1 012-11. Class II As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a slightly greater chance for subsidence or expulsion. RTI Surgical, Inc.
Devices Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients. Software Part number 4-070212-85, revision AB-AG Class I Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error. Covidien
Food Hood brand Fat Free Chocolate Milk, 8 oz. UPC: 0 44100 11244 7 Sell by Date: DEC 31 2014 xx:xx 42-207 L1 Class II Product labeled with an extended sell by date HP Hood LLC
Devices Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting. All Lots for MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. Class II During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cutter/burr fracture. The Anspach Effort, Inc.
Devices Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone. Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control) Class II Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD). The Anspach Effort, Inc.
Devices Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone. Serial # 50152011-14 (B-Blue-S) Serial # 31447408 (B-Green) Class II Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD). The Anspach Effort, Inc.
Devices On Site Gas Systems POGS 33C Portable Oxygen Generation System Serial Numbers: 4220FA 4221FA 4222FA 4223FA 4224FA 4225FA 4226FA 4227FA 4228FA 4229FA 4230FA 4231FA 4232FA 4233FA 4234FA 4235FA 4236FA 4237FA 4238FA 4239FA 4240FA 4241FA 4242FA 4243FA 4244FA 4245FA 4246FA 4247FA 4248FA 4249FA 4250FA 4251FA 4252FA 4253FA 4254FA 4255FA 4256FA 4257FA 4258FA 4259FA 4260FA 4261FA 4262FA 4263FA 4264FA 4265FA 4266FA 4267FA 4268FA 4269FA 4270FA 4271FA 4272FA 4273FA 4274FA 4275FA 4276FA 4277FA 4278FA 4279FA 4280FA 4281FA 4282FA 4283FA 4284FA 4285FA 4286FA 4287FA 4288FA 4289FA 4290FA 4291FA 4292FA 4293FA 4294FA 4295FA 4296FA 4297FA 4298FA 4299FA 4300FA 4301FA 4302FA 4303FA 4304FA 4305FA 4306FA 4307FA 4308FA 4309FA 4310FA 4311FA 4312FA 4313FA 4314FA 4315FA 4316FA 4317FA 4318FA 4319FA 4320FA 4322FA 4323FA 4324FA 4325FA 4326FA 4327FA 4328FA 4329FA 4330FA 4331FA 4332FA 4333FA 4334FA 4335FA 4336FA 4337FA 4338FA 4339FA 4340FA 4341FA 4342FA 4343FA 4344FA 4345FA 4346FA 4347FA 4348FA 4349FA 4350FA 4351FA 4352FA 4353FA 4354FA 4355FA 4356FA 4357FA 4358FA 4359FA 4360FA 4361FA 4362FA 4363FA 4364FA 4365FA 4366FA 4367FA 4368FA 4369FA 4370FA 4371FA 4372FA 4373FA 4374FA 4375FA 4376FA 4377FA 4378FA 4379FA 4380FA 4381FA 4382FA 4383FA 4384FA 4385FA 4386FA 4387FA 4388FA. 4389FA 4390FA 4391FA 4392FA 4393FA 4394FA 4395FA 4396FA 4397FA 4398FA 4399FA 4400FA 4401FA 4402FA 4403FA 4404FA 4405FA 4406FA 4407FA 4408FA 4409FA 4410FA 4411FA 4412FA 4413FA 4414FA 4415FA 4416FA 4417FA 4418FA Class II Heat exchanger hose becomes weak and may fail. On Site Gas Systems Inc.
Devices Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user. Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722. Class II The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled. Invacare Corporation
Food Organic Almonds: Baugher Ranch Organics; Certified Organic by California Organic Farmers May Contain occasional Shell fragments. Keep Refrigerated; 25 lbs. Baugher Farms, Orland, CA Lot number BR08-13A23-1333803; Expiration date June 2015 Class II Potential for metal fragments in product after a single wire from metal detector was confirmed to be cut into fragments and not all pieces are accounted for. Baugher Ranch Organics, Inc
Devices Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. All units shipped prior to Octotber 18, 2013. US Serial numbers: 44055311, 44055611, 44055811, 44056012, 44056312, 44056612, 44056712, 44056812, 44057312, 44057812, 44058012, 44058212, 44058312, 44059212, 44059312, 44059612, 44059712, 44059812, 44059912, 44060012, 44060112, 44060312, 44060412. International Serial numbers: 44000811, 44055211, 44055411, 44055711, 44055911, 44056112, 44056212, 44056412, 44056512, 44056912, 44057012, 44057112, 44057212, 44057412, 44057512, 44057612, 44057712, 44057912, 44058112, 44058512, 44058612, 44058912, 44059012. 44059112 44059412 44059512 44060212 44060512 44061112 44061212 44061312 44061512 44061712 44061913 44062113 44062313 44062513 44062913 44063013 44060612 44060712 44060912 44061012 44061412 44061612 44061812 44062013 44062213 44062613 44062813 44063313 44063513 44063613 44063713 44063913. Class II Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke. Optimedica Corporation
Devices SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Mfg Lot or Serial # SA307140598GA SA307140599GA SA307140600GA SA307140601GA SA307140605GA SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140612GA SA307140614GA SA307140615GA SA307140618GA SA307140619GA SA307140622GA SA307140623GA SA307140627GA SA307140628GA SA307140631GA SA307140632GA SA307140636GA SA307140637GA SA307140639GA SA307140640GA SA307140641GA SA307140642GA SA307140644GA SA307150645GA SA307150646GA SA307150655GA SA307150656GA SA307020391GA SA307030405GA SA307030424GA SA307070446GA SA307070447GA SA307070448GA SA307080462GA SA307080463GA SA307080484GA SA307080508GA SA307080523GA SA307110548GA SA307110556GA SA307110571GA SA307190716GA SA307190737GA SA307190739GA SA307190750GA SA307190768GA SA307020379GA SA307020384GA SA307020386GA SA307030407GA SA307030409GA SA307030412GA SA307030414GA SA307060432GA SA307070436GA SA307070440GA SA307070441GA 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produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup. GE Healthcare, LLC
Devices NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2766916 2781527 2776455 2767054 2768331 2770578 2781554 2785375 2767355 2783362 2787992 34-463-HE Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2781528 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave®, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2776452 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave® (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave ®, NanoClave® T-Connector, Rotating Luer, Part No. A1000, Item No. 011-A1094 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Item No. 011-A1094. Lot No. 2776971, 2785649, 2796670. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave®, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave®, NanoClave® TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1095 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Item No. 011-A1095. Lot No. 2776972, 2785650, 2796669. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave®, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave® TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1097 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Item No. 011-A1097. Lot No. 2781155, 2796667. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2781529 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 17 cm (7'') Ext Set w/NanoClave®, 2 Gang 4-Way NanoClave® Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2788003 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave® TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2773810 2777115 2781555 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave® Clear, NanoClave®, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2740579 2767063 2771738 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE® Clear, NanoClave® T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2770580 2774284 2777867 2781557 2782915 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE® Clear, 0.2 Micron Filter, NanoClave® T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2770581 2774286 2777870 2781558 2790342 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 78" Ext Set w/Check Valve, CLAVE® Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave®, NanoClave® T-Connector, 4 Clamps, Rotating Luer, 3 Ext, Part No. A1000, Item No. A1026 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2773123 2777666 2781424 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2788311 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2773045 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2773046 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2773047 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave®, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave®, Part No. A1000, Item No. A1078 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2764552 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave®, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2777116 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave® Clear, NanoClave®, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2776502 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. A1093 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2773813 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2764741 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767356 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767357 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave® Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767359 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave® Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.anoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7089-001 Lot No. 2784699 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave® Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767361 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave® Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767362 2782698 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. K7093-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2778180 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 78" Ext Set w/2 BCV-Clave®, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No. K7094-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767012 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767364 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767365 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767366 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767368 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave® Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7101-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2784698 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave® Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767371 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767372 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767374 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave® Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767375 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2767376 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE® Stopcock, Remv CLAVE® Stopcock, NanoClave® T-Connector, Rotating Luer, 1 Ext, Part No. A1000, Item No. SC124 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Item No. SC124. Lot No. 2774006, 2778500, 2783068, 2794495. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 120" 10 Drop Primary Set w/2 BCV-CLAVE®, Remv 2 Gang CLAVE® Stopcock, Remv CLAVE® Stopcock, NanoClave® T-Connector, Rotating Luer, 2 Ext, Part No. A1000, Item No. SC125 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 2774004 2776121 2778498 2783073 2790601 Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Lot No. 34-892-HE Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 5" Smallbore Ext Set w/MicroClave® T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Item # B33101-T, Lot # 2791358. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 5" Smallbore Ext Set w/MicroClave® T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. B3303-T, Lot # 2791243. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 5" Smallbore Ext Set w/MicroClave® T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Item # B3304-T, Lot # 2791244. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave® T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Item # B33071-T, Lot # 2791245. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave® Clear, NanoClave® T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Item # A1099, Lot # 2791393. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE® Clear, Clamp, NanoClave® T-Connector, Rotating Luer, Item # A1003, Lot # 2773812. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Item # A1003, Lot # 2773812. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Devices 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave® ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. Item #011-A1096, Lot # 2796668. Class II ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ICU Medical, Inc.
Drugs Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05. Lot # 244152A, exp 01/15. Class II Presence of Foreign Substance; metal particulates were visually observed in tablets. Watson Laboratories Inc
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