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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm December 02, 2022
Date Posted February 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-1176-2023
Recall Event ID 91324
510(K)Number K981128  
Product Classification Suture, nonabsorbable, silk - Product Code GAP
Product Sofsilk Coated Braided Silk Suture Product Description
CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211
CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490
CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562
GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823
GS-835 SOFSILK* 1 BLK 75CM V20 X36 GS835
S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S1172
S-1173 SOFSILK* 5-0 BLK 45CM C1 X36 S1173
S-1174 SOFSILK* 4-0 BLK 45CM C1 X36 S1174
S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S1750K
S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176
S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176
S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S1768K
S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S182
S-183 SOFSILK* 4-0 BLK 12X45CM PCT X36 S183
S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S184
S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S185
S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S187
S-206 SOFSILK* 2 BLK 100CM STDLTH X36 S206
S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S243
S-244 SOFSILK* 3-0 BLK 12X60CM PCT X36 S244
S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S245
S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S246
S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S2782K
S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S303
S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S304
S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S305
S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S316
S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S317
S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S318
S-346 SOFSILK* 0 BLK 12X60CM PCT X24 S346
S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S605
S-607 SOFSILK* 1 BLK 2X150CM PCT X36 S607
S-608 SOFSILK* 2 BLK 2X150CM PCT X36 S608
SS-523 SOFSILK* 2-0 BLK 75CM SC1 X36 SS523
SS-525 SOFSILK* 1 BLK 75CM SC1 X36 SS525
SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS5641
SS-5641G SOFSILK* 4-0 BLK 45CM P13 X12 SS5641G
SS-5678 SOFSILK* 5-0 BLK 45CM P11 X36 SS5678
SS-5684 SOFSILK* 3-0 BLK 45CM P14 X36 SS5684
SS-623 SOFSILK* 2-0 BLK 75CM SC2 X36 SS623
SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS645
SS-653 SOFSILK* 4-0 BLK 75CM C13 X36 SS653
SS-673 SOFSILK* 5-0 BLK 75CM C12 X36 SS673
SS-683G SOFSILK* 4-0 BLK 45CM C13 X12 SS683G
SS-685G SOFSILK* 2-0 BLK 45CM C15 X12 SS685G
SS-686 SOFSILK* 4-0 BLK 45CM C12 X12 SS686
SS-689 SOFSILK* 1 BLK 75CM C16 X36 SS689
SS-745 SOFSILK* 3-0 BLK 75CM C12 X36 SS745
SS-786 SOFSILK* 0 BLK 75CM C14 X36 SS786
SS-787 SOFSILK* 1 BLK 75CM C14 X36 SS787
VS-533 SOFSILK* 2-0 BLK 90CM V20 DAX36 VS533
VS-845 SOFSILK* 1 BLK 75CM V26 X36 VS845
VS-870 SOFSILK* 5-0 BLK 75CM CV23 X36 VS870
VS-871 SOFSILK* 4-0 BLK 75CM CV23 X36 VS871
SOFSILK 4-0 30 BK CV-23 VS871-2 VS8712
VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872
SOFSILK 3-0 30 BK CV-23 VS872-2 VS8722
VS-882 SOFSILK* 3-0 BLK 75CM CV15 X36 VS882
SOFSILK 5-0 30 BK CV-11 VS890-2 VS8902
XX-5278 SOFSILK* 3-0 BLK 150CM PCT X36 XX5278
XX-5280 SOFSILK* 0 BLK 150CM PCT X36 XX5280
XX-5281 SOFSILK* 1 BLK 150CM PCT X36 XX5281
XX-5284 SOFSILK* 4 BLK 150CM PCT X36 XX5284
Code Information GTIN: 20884521086781, 20884521758060, 20884521088136, 20884521088525, 20884521087504, 20884521085289, 20884521087672, 20884521087481, 20884521090566, 20884521086712, 20612479214235, 10884521084698, 20884521084695, 20884521085166, 20884521087580, 10884521087583, 20884521089256, 20884521088532, 20884521087719, 20884521090160, 10884521090163, 20884521087900, 20612479214419, 20884521083629, 20884521085944, 20884521086668, 20884521087399, 10884521086142, 20884521086149, 10884521086623, 20884521086620, 20884521106106, 20884521085968, 20884521086484, 20884521086491, 10884521086494, 20884521088624, 10884521086661, 20884521086170, 20884521085951, 10884521086463, 20884521086460, 20884521086187, 10884521085787, 20884521085784, 20884521085517, 20884521090184, 20612479214495, 20884521090153, 20884521086651, 10884521085510, 20884521088464, 20884521088129, 20884521086194, 10884521086197, 20884521086552, 10884521087484, 20884521085982, 10884521085985, 20884521086477, 20884521106021, 20884521106052, 20884521757926, 10884521083622, 20612479213283, 20884521090115, 10884521090118, 20884521085746, 20884521087429, 20884521086774, 20884521085975, 20884521088143, 20884521086705, 20884521085470, 20884521085500, 20884521084671, 10884521084674, 20884521758039, 20612479213269, 10884521085169, 20884521086514, 20884521086200, 20884521106045, 20884521085739, 20884521086422. Model Number Lot # CS211 D1L1576Y D2B0747Y CS490 D2C2519Y CS562 D1G1928Y GS823 D1K1923Y D2D1396Y GS835 D1E1757Y S1172 D2C2304Y S1173 D2C2305Y D2E1385Y S1174 D1M1794FY D1M2954FY D1M2984FY S1750K D2E2348Y S176 D2B1886Y S176 D2C1977Y S1768K D1M1759Y D2B2217Y S182 D1L1613Y D2B0177Y S183 D1M1421Y D2E1280Y S184 D1L3136Y D1M2895Y D2D0954Y D2D0964Y D2D0967Y D2D0972Y S185 D2B2785Y D2B2877Y D2B2878Y D2C1421Y D2D0957Y D2D0968Y D2D0971Y D2D0984Y D2D0985Y D2E2680Y D2E2767Y D2E2769Y S187 D2A1585Y S206 D1L2658Y D1M2896Y D2A1586Y S243 D1M1020Y D2D2348Y S244 D1M1590Y S245 D2A0559Y D2C2036Y D2C2162Y D2D1871Y S246 D2E1375Y S2782K D2F0062Y S303 D1M1424Y D2C1472Y D2D1872Y D2D2120Y D2E1496Y S304 D2B0173Y D2C2163Y D2C2805Y D2D1991Y D2E1484Y S305 D1L3282Y D1L3459Y D2C1280Y D2C1281Y D2C1479Y D2D0959Y D2E0907Y D2E2768Y D2E2772Y S316 D1L3311Y D1M0530Y D2A0555Y D2A0557Y D2A0558Y D2A0866Y D2C2806Y D2D2434Y D2D2436Y S317 D2D2087Y D2E0587Y S318 D1M0153Y D2A1677Y S346 D2A0867Y D2B1884Y S605 D1L2686Y D2B2244Y S607 D1M2899Y S608 D1L1617Y D1L1619Y D1L1622Y D1M0173Y D1M0635Y D1M0655Y D2E1210Y SS523 D2C1971Y SS525 D1G1346Y SS5641 D2B2181FY SS5641G D1D2533FY SS5678 D1L2430FY SS5684 D2B1970FY SS623 D1G0960Y D2A1069Y SS645 D1K2457FY D1L3151FY D1M2526FY D1M2531FY SS653 D1E2737FY SS673 D1L0164FY SS683G D1L0794FY SS685G D2A0503FY SS686 D1E0201FY SS689 D2C0024FY SS745 D1M2971FY SS786 D1E1220FY SS787 D1L0032FY VS533 D1M0598Y VS845 D2B1779Y VS870 D1M2873Y VS871 D1L0602Y VS8712 D2C3153Y VS872 D1M1837Y D2C2945Y VS8722 D1D3187Y D1M1292Y VS882 D1G1139Y VS8902 D2B0364Y XX5278 D2B0174Y XX5280 D2E1482Y XX5281 D2B0175Y XX5284 D1L2691Y
Recalling Firm/
Manufacturer		 Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Medtronic Customer Service
800-962-9888
Manufacturer Reason
for Recall		 Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
FDA Determined
Cause 2		 Packaging process control
Action Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" letter to US consignees on 01-Dec-2022 via UPS 2-day delivery. OUS countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and actions to take: Actions: " Identify and quarantine all unused and non-expired affected non-absorbable sutures. " Please note the affected product may be located within Custom Suture Packs. Please reference Custom Suture Packs to identify affected product. " Please complete the enclosed Customer Confirmation Form (even if your account no longer has affected product on hand) and email to rs.gmbfcamitg@medtronic.com.> " Return all unused and non-expired affected product in your inventory to Medtronic as indicated in the Shipping and Return Instructions below. " Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed. Shipping and Return Instructions: " Product purchased directly from Medtronic please contact rs.covidienfeedbackcustomerservice@medtronic.com for Return Good Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Credit or Replacement for the returned affected product will be issued based on the RGA number. " Return all unused and non-expired affected product(s) in your inventory to: Medtronic, Attn: Field Returns Dept. 195 McDermott Road, North Haven, CT 06473 USA. " If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888.
Quantity in Commerce 271800 units
Distribution US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GAP and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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