Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall GEOMED BIOPSY TRAY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall GEOMED BIOPSY TRAY see related information
Date Initiated by Firm February 07, 2011
Date Posted May 20, 2011
Recall Status1 Terminated 3 on August 06, 2014
Recall Number Z-2229-2011
Recall Event ID 58675
Product Classification Tray, surgical - Product Code LRP
Product Kits and Trays containing alcohol swabstick/prep pad:
GEO-MED BIOPSY TRAY, V A MED CTR MARTINSBURG, REF 89-7617.01
Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) ST TPN/CVC DRG KIT W/VAD, REF 47-003, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TPN/CVC Dressing Change Kit, REF 47-094.019, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TPN/CVC DRG CHG KIT, REF 47-276.13, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST CEN LINE KIT, REF 47-324, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST PED TRAY, REF 47-327, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST MAYO CLINIC PICC KIT, REF 47-483, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST PICC DRG CHG KIT, REF 47-491.12, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST IHC DRG CHG KIT, REF 47-600, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, Made in the Dominican Republic; DeRoyal (R) PRESBYT PIC KIT-NICU, REF 47-626.10, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST NEONATAL DRG CHG KIT, REF 47-670.05, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW PREP TRAY, UNIV OF ROCHESTER, REF 47-743.01, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA;
DeRoyal (R) St. Central Line Kit, REF 47-777.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA;
DeRoyal (R) ARTERIAL LINE HYPER TRAY-25C, UNIV VIRGINIA CHARLOTTESVILLE, REF 50-3474.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW BIOPSY, UNIVERSITY OF WASHINGTON, REF 89-3899.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BIOPSY TRAY, PARKWAY RADIOLOGY, REF 89-6306.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ARTERIAL LINE TRAY, ERLANGER MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST DRESSING CHANGE KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST DIALYSIS KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TRN/CVC DRG KIT W/TRANS, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CVC Dressing Change Kit, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA
Code Information REF 89-7617.01: Lot Number 23700991; REF 47-003: Lot Numbers: 19930881, 14034148, 15104953; REF 47-094.019: Lot Number 20508661, REF 47-276.13: Lot Numbers: 17602649, 19555209, 20376793, 21093681, 22419187, 22683210, 24979698; REF 47-324: Lot Numbers: 17889221, 18103956, 18198174, 18782311, 19462176, 19930911, 20508688, 20841051, 21885303, 22898544, 23264965, 23909381, 24461442, 24721435, 24826376, 24870174, 24926879, 25051242; REF 47-327: Lot Numbers: 17830692, 18507723, 20434261, 20504978, 20689600 20796333; REF 47-483: Lot Numbers: 14128591, 18477552, 18871373, 19042121, 19251900, 19990972, 20189171, 20795058, 21097260, 24023557, 24095500, 24174697, 24203283, 24248043, 24808987; REF 47-491.12: Lot Numbers: 17784008, 18987974, 21361438, 22373001, 22772933, 22947297; REF 47-600: Lot Numbers: 17094939, 17217214, 17243463, 17538026, 17738634, 18550713, 18982727, 19491612, 20576681, 20597545, 20779787, 20873001, 21667226, 22195671, 22830380, 23278187, 24059576, 24220391; REF 47-626: Lot Numbers: 17227623, 17295327, 18507766, 18521306, 19310383, 19930953, 20503570, 21092194, 21521083, 22373043, 23251232, 23904248; REF 47-670.05: Lot Numbers: 17022468, 17390957, 18563750, 18755903, 19668318, 19930961, 21474248, 21617051, 22142755, 24310871; REF 47-743.01: Lot Numbers: 17841990, 18452507, 19327100, 19703814, 20178308, 21924659, 22354192, 22900561, 24311516, 24663458, 24924136; REF 47-777.02: Lot Numbers: 17594853, 17832541, 18987982, 19010591, 19313040, 19584712, 21339177, 21821158, 22934681, 23705839, 23846199, 24809496; REF 50-3474.02: Lot Numbers: 18588210, 19507080; REF 89-3899.01: Lot Numbers: 17880972, 18177197, 18691938, 18710967, 18909781, 19021821, 19213727, 19323002, 19517270, 19879799, 20009395, 20207308, 20495637, 21055140, 21317453, 21827031, 21839201, 22057382, 22731285, 22849558, 23336324, 23531023, 23778991, 24005738, 24746747, 24822480; REF 89-6306.02: Lot Numbers: 17682829, 17781843, 17884746, 19328381, 19569264, 19845329, 19883659, 20013571, 20371095, 20894128, 21500557, 21687016, 21841853, 22059839, 22736449, 23621889, 23879134, 24009798, 24294533, 24521222; REF 89-7650.01: Lot Number 24631085; REF 47-746.04: Lot Numbers: 17283351, 17537736, 17669261, 17796391, 18493296, 18750635, 18958621, 18982583, 19407302, 19690523, 20547257, 20597916, 20662280, 20936851, 21149437, 21544832, 21666944, 21707355, 21775500, 23074715, 23683203; REF 47-501: Lot Numbers: 18507758, 18521293, 18624479, 19555225, REF 47-004: Lot Numbers: 22898536, 17138831, 18755831, 20697511, 21116791; REF 47-751: Lot Numbers: 18429569, 19668529
Recalling Firm/
Manufacturer		 Deroyal Industries, Inc. Lafollette
1501 East Central Ave
La Follette TN 37766-2892
For Additional Information Contact Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		 Custom surgical kits contained either one or more of the following possible contaminated recalled products: Triad lubricating jelly, alcohol prep pads, and alcohol swabs.
FDA Determined
Cause 2		 Other
Action DeRoyal notified their consignees by letter with the subject line "Re: DeRoyal Recall of Triad Medical Lubricating Jelly, Alcohol Prep Pads and Alcohol Swabs" on 02/07/2011 that kits in their possession contained recalled Triad products that were possibly contaminated. Customers were to use the attached spreadsheet to identify and quarantine the affected product. The spreadsheet should have been completed even if there was no affected product. The form should have been faxed back to 865-362-3716 or emailed to recalls@deroyal.com. Customers' DeRoyal Sales Representative would re-label the affected product in order to prevent further use. The DeRoyal Sales Representatives are also providing in-service training on effectuating this recall, including the importance of identifying, retrieving and discarding the recalled products as well as the documentation necessary to account for these products. Distributors were directed to recall down to the retail level. If there are questions or if further assistance is needed, customers can contact their DeRoyal Sales Representative or customer support department at 1-800-251-9864.
Quantity in Commerce 340,976 units total
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-