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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-1174-2023
Recall Event ID 91324
510(K)Number K900531  
Product Classification Suture, nonabsorbable, synthetic, polyamide - Product Code GAR
Product Monosof Monofilament Nylon sutures:
Product Description

CN-724 MONOSOF* 1 BLK 100CM GS25 X36
CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36
CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90
CN-793 MONOSOF* 1 BLK 100CM GCC90 X36

CN-793-12 MONOSOF* 1 BLK 100CM GCC90X12
CN-830-L MONOSOF* 1 BLK 150CM LP GS25
N-2781K MONOSOF* 5-0 BLK 45CM SS24 DAX12
SN-1647 MONOSOF* 7-0 BLK 45CM P16 X36
SN-1647G MONOSOF* 7-0 BLK 45CM P16 X12
SN-247 MONOSOF* 3-0 BLK 90CM C23 X36

SN-3686 MONOSOF* 7-0 BLK 45CM P10 X12

SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12



SN-3697 MONOSOF* 6-0 BLK 45CM P10 X12

SN-3965 MONOSOF* 5-0 BLK 45CM PC11 X12
SN-5660G MONOSOF* 6-0 BLK 45CM P24 X12
SN-5665G MONOSOF* 6-0 BLK 45CM P12 X12
SN-5690G MONOSOF* 5-0 CLR 45CM P13 X12
SN-5691 MONOSOF* 4-0 CLR 45CM P13 X36
SN-5694 MONOSOF* 4-0 BLK 45CM P11 X36
SN-5696 MONOSOF* 6-0 BLK 45CM P13 X36
SN-5697 MONOSOF* 6-0 BLK 45CM P10 X36
SN-5767G MONOSOF* 6-0 BLK 45CM P11 X12
SN-630 MONOSOF* 4-0 BLK 75CM C22 X36
SN-643 MONOSOF* 5-0 BLK 75CM C13 X36
SN-667G MONOSOF* 6-0 BLK 45CM C1 X12
SN-694 MONOSOF* 2-0 BLK 90CM C18 X36
SN-871 MONOSOF* 5-0 BLK 45CM C1 X36
SN-872 MONOSOF* 4-0 BLK 45CM C1 X36

SUT GNJ-283 MONOSOF 2/0 BLK ST DA 90CM

SUT N-59 MONOSOF 2-0 BLK 6X45CM PCT
Code Information GTIN: 20884521075105, 20884521075235, 10884521075238, 20884521075143, 10884521635395, 20884521077857, 20884521075372, 20884521078090, 20884521077994, 20884521079073, 10884521080348, 20884521080345, 20884521080321, 10884521080324, 10884521078758, 20884521078755, 20884521078182, 20884521078045, 20884521075129, 10884521635371, 20884521127675, 20884521079844, 20884521079028, 20884521079325, 10884521079328, 20884521079097, 10884521079090, 20884521079202, 20884521079448, 20884521076829, 10884521075146, 20884521080093, 20884521079042, A8845210765103, 20884521076812, 20884521077987, 20884521079134, 10884521079137, Model # Lot # CN-724 D1B2528Y CN-791 D1L1776Y CN-79112 D1L1776Y CN-793 D1D2772Y D2B2754Y CN-79312 D1D2772Y CN-830-L D1D2705Y N-2781K D1L2330Y SN-1647 D2E2028FY SN-1647G D2B2227FY SN-247 D1D3222FY D2B0043FY SN-3686 D2E2761FY D2F0402FY SN-3695 D1G0954FY D1L0957FY D2C1333FY D2E2762FY SN-3697 D1L1710FY D2C1211FY SN-3965 D1E1222Y SN-5660G D1L0922FY SN-5665G D1L0774FY SN-5690G D1M1283FY SN-5691 D2D0703FY SN-5694 D1J1230FY SN-5696 D1M2419FY SN-5697 D2F0399FY SN-5767G D2A0554FY SN-630 D1M1286FY SN-643 D2B0369FY SN-667G D1L2502FY SN-694 D2C0324FY SN-871 D1K3362FY SN-872 D1K2654FY D1M2450FY GNJ-283 D1E0555Y D1E0750Y N-59 D2D2350Y
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 54288 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 = GAR and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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