BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-1180-2023 · Initiated December 2, 2022

    Recall

    Recall Number
    Z-1180-2023
    Event Number
    91324
    FEI Number
    1219930
    Product Code
    GAW
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    December 2, 2022
    Posted
    February 25, 2023
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    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

    Reason

    Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

    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 [email protected].> " 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 [email protected] 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.

    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

    Quantity

    322152 units