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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-1180-2023
Recall Event ID 91324
510(K)Number K050947  
Product Classification Suture, nonabsorbable, synthetic, polypropylene - Product Code GAW
Product Surgipro II Monofilament Polypropylene Sutures
Product Description Model Number
VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X
VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X
VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X
VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X
VP-735-X SURGIPRO*II 7-0 60CM MV1758DA VP735X
VP735X-12 SURGIPRO*II 7-0 60CM MV1758 DA VP735X12
VP-738-X SURGIPRO*II 8-0BLU 60CM CV351DA VP738X
VP-744-X SURGIPRO*II 8-0 45CM MV1758DA VP744X
VP-745-X SURGIPRO*II 8-0 60CM MV1758DA VP745X
VP-747-X SURGIPRO*II 7-0 75CM MV1758DA VP747X
VP-853 SURGIPRO* 2-0 BLU 120CM V26 DA VP853
VP-875-X SURGIPRO*II 7-0 75CM MV1759DA VP875X
VP-900-X SURGIPRO*II 8-0 45CM MV1355DA VP900X
VP-902-X SURGIPRO*II 8-0 60CM MV1355DA VP902X
VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X
VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X
VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X
VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X
VP-735-X SURGIPRO*II 7-0 60CM MV1758DA VP735X
VP735X-12 SURGIPRO*II 7-0 60CM MV1758 DA VP735X12
VP-738-X SURGIPRO*II 8-0BLU 60CM CV351DA VP738X
VP-744-X SURGIPRO*II 8-0 45CM MV1758DA VP744X
VP-745-X SURGIPRO*II 8-0 60CM MV1758DA VP745X
VP-747-X SURGIPRO*II 7-0 75CM MV1758DA VP747X
VP-853 SURGIPRO* 2-0 BLU 120CM V26 DA VP853
VP-875-X SURGIPRO*II 7-0 75CM MV1759DA VP875X
VP-900-X SURGIPRO*II 8-0 45CM MV1355DA VP900X
VP-902-X SURGIPRO*II 8-0 60CM MV1355DA VP902X12
VP-904-X SURGIPRO*II 7-0 BLU 60CM MV1355 VP904X
VPF-735-X SURGIPRO*II 7-0 60CM MVF1758DA VPF735X
XX-3300 SURGIPRO* II 5-0 BLU 60CM CV1DA XX3300
XX-5224 SURGIPRO*II 5-0 BLU 90CM CV25DA XX5224
Code Information GTIN: GTIN 20884521039534 20884521038902 20884521039596 20884521038810 10884521038813 20884521039565 10884521039568 20884521039466 10884521039469 10884521640061 20884521038940 10884521038943 20884521038841 20884521038896 10884521039599 10884521038905 10884521037717 20884521037714 10884521037748 20884521037745 10884521640276 20884521039404 20884521037844 20884521037851 20884521758558 20884521758664 10884521039537 10884521038844 Model Number Lot # VP421X D2C1147Y VP435X D2C1148Y D2D0080Y D2D0081Y D2D1507Y D2E1343Y VP541X D2E0506Y D2E0507Y VP542X D2E0749Y D2E0750Y VP735X D0M2060Y D0M2061Y D1A0234Y D1A0419Y D1A0420Y D1A0474Y D1A0479Y D1A0480Y D1A0499Y D1A0960Y D1A1636Y D1B0024Y D1B0513Y D1B1462Y D1B2759Y D1B2760Y D1B2784Y D1B2785Y D1G2405Y D1G2406Y D1H1658Y D1H1945Y D1H1971Y D1H2033Y D1H2104Y D1H2105Y D1H2106Y D1H2107Y D1J0372Y D1J0374Y D1J0375Y D1J0376Y D1J0591Y D1J1260Y D1J1679Y D1J1923Y D1J1928Y D1J1929Y D1J2885Y D1K2644Y D1L0457Y D1L3332Y D1M0869Y D1M0870Y D1M0963Y D1M1464Y D2B0362Y D2C1982Y D2C2348Y D2D0155Y D2D0156Y D2D0166Y D2D0942Y D2D2100Y D2E0165Y D2E0173Y D2E0175Y D2E1035Y D2E1073Y D2E1536Y D2E2752Y D2F1973Y D2F1974Y D2F1975Y VP735X12 D1B2760Y D2D0941Y VP738X D1G0407Y D2C1983Y D2F0494Y D2F0495Y D2F0496Y VP744X D1G0408Y VP744X D1L0327Y VP745X D0M1980Y D1A1635Y D1G1298Y D1H2487Y D1H2488Y D1J0373Y D1J1210Y D1J2362Y D1J2364Y D1J2366Y D1J2541Y D1J2543Y D1K0073Y D1K2317Y D1K2318Y D1K2319Y D1K2326Y D1K2328Y D1K2329Y D1K2642Y D1K2646Y D1K2647Y D1K2648Y D2B0470Y D2B1158Y D2C1984Y D2D0944Y D2D0945Y D2E1923Y D2F0798Y D2F0799Y VP747X D1C0229Y D1C0230Y D1C1787Y D1C1849Y D1G0404Y D1G0405Y D1G2408Y D1M1397Y D1M1465Y D2A0334Y D2D0158Y D2E1074Y VP853 D2D0641Y VP875X D1A1244Y D1E0734Y D1H0909Y D1J1926Y D1K2643Y D1L0605Y D1L2328Y D1M2164Y D1M2165Y D2C0956Y D2E1883Y D2F0936Y VP900X D0K3052Y D1H1373Y D1H1374Y D1H1375Y D1H1457Y D1L0158Y D1L0159Y D1L1321Y D1L2329Y D1L2617Y D1L2618Y D1M1597Y D2A0335Y D2C1926Y D2F0041Y D2F0042Y VP902X D1A1236Y D1A1238Y D1A1240Y D1A1242Y D1A1526Y D1B1245Y D1B1246Y D1B1265Y D1B1954Y D1B2137Y D1B2688Y D1C0681Y D1C1270Y D1C2801Y D1C2817Y D1D0141Y D1D0411Y D1D0687Y D1D1498Y D1D1499Y D1D1570Y D1D2580Y D1D2693Y D1D3578Y D1D3629Y D1E0582Y D1E0583Y D1E2328Y D1E3445Y D1F0032Y D1F0519Y D1F0521Y D1F1704Y D1F2371Y D1G3162Y D1H0384Y D1H0411Y D1H0899Y D1H0901Y D1H0902Y D1H0904Y D1H0905Y D1H0906Y D1J0586Y D1J0597Y D1J0598Y D1J0599Y D1J0993Y D1J1258Y D1J1623Y D1J1832Y D1J2361Y D1J2365Y D1J2542Y D1K0111Y D1K0519Y D1K2349Y D1K2350Y D1K2416Y D1K2417Y D1K2418Y D1K2419Y D1K2573Y D1K2576Y D1K2632Y D1K2645Y D1L3382Y D1L3383Y D1M0015Y D1M0016Y D1M0151Y D1M0166Y D1M0169Y D1M0299Y D1M0300Y D1M1031Y D1M2836Y D1M2839Y D1M2841Y D2A0336Y D2A0338Y D2A1717Y D2A1718Y D2B0361Y D2B0469Y D2B1062Y D2B1063Y D2B1255Y D2B1257Y D2C0951Y D2C0952Y D2C1330Y D2C1331Y D2C1927Y D2C1928Y D2C2398Y D2C2399Y D2C2400Y D2C2401Y D2C2509Y D2C2738Y D2D0097Y D2D0098Y D2D0099Y D2D0162Y D2D0163Y D2D0167Y D2D0168Y D2D0169Y D2D2005Y D2E0167Y D2E0168Y D2E0169Y D2E0170Y D2E0171Y D2E0172Y D2E0174Y D2E1528Y D2E1529Y D2E1531Y D2E1845Y D2E1884Y D2E1885Y D2E1922Y D2E2097Y D2G0697Y VP902X12 D2C1928Y D2G0697Y VP904X D0M1981Y D1B0657Y D1C1118Y D1D2622Y D1G1296Y D1G1299Y D1G1999Y D1J2884Y D1M0345Y D1M2834Y D2A0337Y D2B1159Y D2E1078Y VPF735X D1G1297Y D1K0520Y D1M1046Y D1M1557Y D2E1079Y XX3300 D2F2287Y XX5224 D2D0804Y
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 322152 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 = GAW and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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