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U.S. Department of Health and Human Services

Class 2 Device Recall Regard

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  Class 2 Device Recall Regard see related information
Date Initiated by Firm November 09, 2020
Create Date December 28, 2020
Recall Status1 Terminated 3 on May 13, 2021
Recall Number Z-0737-2021
Recall Event ID 86830
Product Classification Gauze/sponge, internal - Product Code EFQ
Product Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges.

1) Regard, PACEMAKER, Item 800221010, Lot # 82466.
2) Regard, BASIC, Item 800109003 Lot # 83411.
3) Regard, MAJOR EAR, Item 800070009, Lot # 82442.
4) Regard, NEURO, Item 800040011, Lot # 82504.
5) Regard, LAP CHOLE, Item 800003011, Lot # 82497.
6) Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490.
7) Regard, CERVICAL, Item 800058007, Lot # 82592.
8) Regard, ARTHROSCOPY, Item 800027008, Lot # 82582.
9) Regard, MAJOR SURGERY, Item 800013010, Lot # 82844.
10) Regard, GENERAL SURGERY, Item 800057012, Lot # 82832.
11) Regard, SEPTO SINUS ENDO, Item 800024006, Lot # 82876.
12) Regard, MINOR FMOL-LADY OF THE LAKE, Item 800019009, Lot # 82893.
13) Regard, KNEE ARTHRO, Item 800072009, Lot # 83058.
14) Regard, LAP, Item 800096005, Lot # 83139.
15) Regard, KNEE ARTHROSCOPY, Item 800121, Lot # 83251.
16) Regard, CYSTOSCOPY, Item 800093007, Lot # 83138.
17) Regard, LAP CHOLE, Item 800035007, Lot # 83257.
18) Regard, PERIPHERAL VASCULAR, Item 800007011, Lot # 83106.
19) Regard, PACEMAKER, Item 800083006, Lot # 82886.
20) Regard, I&D, Item 800056005, Lot # 83135.
21) Regard, HEAD & NECK, Item 800068010, Lot # 83050.
22) Regard, ROBOTICS, Item 800103007, Lot # 83264.
23) Regard, MAJOR EAR, Item 800070010, Lot # 82879.
24) Regard, ORTHO EXTREMITY, Item 800042009, Lot # 83383.
25) Regard, CRANIOTOMY, Item 800025015, Lot # 83271.
26) Regard, MINOR ORTHO, Item 800020007, Lot # 83583.
27) Regard, VATS, Item 800118001, Lot # 83421.
28) Regard, ARTHROSCOPY, Item 800027008, Lot # 83560.
29) Regard, OPEN HEART, Item 800023010, Lot # 83273.
30) Regard, PERIPHERAL VASCULAR, Item 800018011, Lot # 83575.
31) Regard, GENERAL PROCEDURE, Item 800000008, Lot # 83576.
32) Regard, DR WHITE OPEN HRT A&B, Item 800045012, Lot # 82847.
33) Regard, NEURO, Item 800008008, Lot # 83598.
34) Regard, LAPAROSCOPY, Item 880320008, Lot # 82472.
35) Regard, PACEMAKER, Item 880074023, Lot # 82417.
36) Regard, THYROID, Item 880425002, Lot # 82389.
37) Regard, LAPAROSCOPY, Item 880350012, Lot # 82473.
38) Regard, CHEST, Item 880373005, Lot # 82427.
39) Regard, BASIC CATARACT, Item 880348006, Lot # 82501.
40) Regard, CCOR HAND, Item 880337009, Lot # 82496.
41) Regard, CRANIOTOMY, Item 880396004, Lot # 82507.
42) Regard, TUR CYSTO, Item 880357006, Lot # 82574.
43) Regard, TOTAL HIP, Item 880266, Lot # 82478.
44) Regard, DAVINCI, Item 880132021, Lot # 82469.
45) Regard, KNEE ARTHROSCOPY, Item 880368, Lot # 82485.
46) Regard, UROLOGY, Item 880306010, Lot # 82584.
47) Regard, MINOR BREAST, Item 880195017, Lot # 82588.
48) Regard, LABOR & DELIVERY, Item 880081018, Lot # 82600.
49) Regard, PELVIC PROCEDURE, Item 880214016, Lot # 82597.
50) Regard, CCOR MINOR, Item 880336010, Lot # 82593.
51) Regard, YOUNG LUMBAR, Item 880432005, Lot # 82594.
52) Regard, PACEMAKER, Item 880418003, Lot # 82606.
53) Regard, LOCAL, Item 880087014, Lot # 82828.
54) Regard, COLON LITHOTOMY, Item 880395002, Lot # 82825.
55) Regard, EYE, Item 880099029, Lot # 82882.
56) Regard, FESS, Item 880404001, Lot # 83033.
57) Regard, CYSTO, Item 880312009, Lot # 82880.
58) Regard, EXTREMITY PACK, Item 880167018, Lot # 82887.
59) Regard, PHERIPHERAL VASC, Item 880077, Lot # 83048.
60) Regard, T & A, Item 880423002, Lot # 83073.
61) Regard, C CABG A & B, Item 880080, Lot # 83042.
62) Regard, DR MARBARGER, Item 880079011, Lot # 83124.
63) Regard, MPR LOCAL, Item 880360006, Lot # 83133.
64) Regard, KNEE ARTHROSCOPY, Item 880268, Lot # 83095.
65) Regard, MINOR PROCEDURE, Item 880261009, Lot # 83132.
66) Regard, EXTREMITY, Item 880262009, Lot # 83071.
67) Regard, LAPAROSCOPY, Item 880102018, Lot # 83238.
68) Regard, GENERAL LAPAROSCOPY, Item 880405002, Lot # 83254.
69) Regard, MAJOR PROCEDURE, Item 880270008, Lot # 83240.
70) Regard, YOUNG LUMBAR, Item 880432005, Lot # 83232.
71) Regard, MINOR LITHOTOMY, Item 88
Code Information Lot Numbers: 82466, 83411, 82442, 82504, 82497, 82490, 82592, 82582, 82844, 82832, 82876, 82893, 83058, 83139, 83251, 83138, 83257, 83106, 82886, 83135, 83050, 83264, 82879, 83383, 83271, 83583, 83421, 83560, 83273, 83575, 83576, 82847, 83598, 82472, 82417, 82389, 82473, 82427, 82501, 82496, 82507, 82574, 82478, 82469, 82485, 82584, 82588, 82600, 82597, 82593, 82594, 82606, 82828, 82825, 82882, 83033, 82880, 82887, 83048, 83073, 83042, 83124, 83133, 83095, 83132, 83071, 83238, 83254, 83240, 83232, 83244, 82872, 83222, 82831, 83263, 83111, 83267, 83261, 83274, 83258, 83266, 83388, 83424, 83417, 83426, 83415, 83427, 83557, 83536, 83540, 83418, 83581, 83550, 83428, 83579, 83296, 83268, 83752, 82591, 82589, 82640, 82813, 82513, 82596, 83069, 82852, 83252, 83101, 83293, 83392, 83572, 83120, 83584, 83422, 83955, 82399, 82474, 82403, 82492, 82509, 82470, 82465, 82491, 82575, 82576, 82521, 82525, 82481, 82577, 82500, 82601, 82607, 82595, 82605, 82519, 82523, 82603, 82625, 82888, 83045, 82855, 83066, 82849, 83036, 83049, 82890, 83242, 83235, 83115, 83064, 83046, 83118, 83245, 83126, 83377, 83134, 83389, 83127, 83286, 83269, 83398, 83292, 83285, 83366, 83423, 83391, 83136, 83445, 83283, 83561, 83545, 83585, 83589, 83580, 83944, 83771. 
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact Cheyenne L. Stewart
417-730-3900
Manufacturer Reason
for Recall		 Gauze sponges contained in custom kits may be flaking or fraying.
FDA Determined
Cause 2		 Component design/selection
Action ROi CPS, LLC on 11/17/2020 sent a notice to its customers with the following instructions: Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the ROi Custom Procedure Kit manufacturer item numbers and lot numbers listed in the above table are in your inventory. 2. REPLY: If the affected kits are identified, please notify ROi CPS, LLC of the quantity on hand by completing the reply form included in this notice. Please email this form to lacy.stewart@roiscs .com . a. If you do not have inventory, please return the form indicating "O" affected inventory at your facility. b. A label template is included with this notice for use in labeling affected kits. The template can be provided to the end users for application to the affected kits in their inventory. 3. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. You may include a copy of this notice and the attached label template with your customer notification. 4. END USERS: End users are instructed not to use the affected Raytec Gauze. Users should remove the affected 4X4 Raytec Gauze, discard and pull replacement product from sterile supply. Post this notice in all areas where the affected kits are used and or stored.
Quantity in Commerce 17,700 total kits
Distribution US Domestic Distribution Only: MO, NC, LA and FL.
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.
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