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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 Medtronicsee related information
Date Initiated by FirmDecember 02, 2022
Date PostedFebruary 25, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1181-2023
Recall Event ID 91324
510(K)NumberK990952 
Product Classification Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
ProductTi-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863035-51 TICRON 2-0 BLU 105CM CV305DA 88863047-41 TICRON* 3-0 BLU 45CM C13X36 88863048-51 TICRON* 2-0 BLU 75CM C13X36 88863050-61 TICRON* 0 BLU 75CM C14 X36 88863054-51 TICRON* 2-0 BLU 75CM C17X36 88863056-89 TICRON* 5 BLU 45CM GS18X12 88863059-53 TICRON* 2-0 BLU 45CM P24X12 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863088-51 TICRON* 2-0 BLU 75CM Y5X36 88863090-51 TICRON 2-0 BLU 75CM GS21X36 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863109-43 TICRON* 3-0 BLU 45CM P22X12 88863111-79 TICRON* 5 BLU 75CM HGS21X36 88863119-61 TICRON* 0 BLU 75CM KV34X36 88863154-09 TICRON* 4 BLU 75CM GS11X36 88863159-31 TICRON* 4-0 BLU 90CM KV5DA 88863160-41 TICRON* 3-0 BLU 90CM Y31DA 88863163-61 TICRON* 0 BLU 75CM SC1 X36 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-41 TICRON* 3-0 BLU 75CM CV331 88863212-51 TICRON* 2-0 BLU 90CM Y5DA7P 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863280-21 TICRON* 5-0 BLU 75CM CV301DA 88863280-31 TICRON* 4-0 BLU 75CM CV301DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 88863369-31 TICRON* 4-0 BLU 90CM CV316DA 88863393-51 TICRON* 2-0 BLU 90CM CV300DA CD-3123K TICRON* 5-0 WHI 45CM SS24 DA
Code Information GTIN: 20884521062303, 20884521059570, 20884521060101, 20884521059006, 20884521059396, 20884521060682, 20884521059013, 10884521059290, 20884521059297, 20884521059280, 10884521061194, 20884521061191, 20884521062327, 20884521059204, 20884521060637, 20884521105192, 20884521062921, 10884521058620, 20884521058627, 20884521060170, 20884521059471, 10884521061293, 20884521061290, 20884521061641, 20884521059020, 10884521060432, 20884521060439, 20884521104300, 20884521063034, 20884521062655, 10884521062320, 10884521059900, 20884521059907, 20884521060361, 20884521059372, 20884521059990, 20884521060095, 20884521059464, 20884521062488, 10884521061507, 20884521061504. Model Number Lot # 8886277531 D1M0276Y 8886288041 D1L1698Y 8886301261 D1D3149FY 8886301561 D1E1922Y 8886301751 D2A0889Y 8886302671 D2C1802Y 8886303551 D1L0984Y 8886304741 D1G1844FY 8886304851 D1G0895FY 8886305061 D2C1969FY 8886305451 D1D3218FY 8886305689 D2D0199Y 8886305953 D1M1287FY 8886307051 D1D2540FY 8886308851 D2B2868Y 8886309051 D2B1332Y 8886309271 D2C2450Y 8886310943 D2C2451FY 8886311179 D1D2597Y 8886311961 D1M1166Y 8886315409 D2B2884Y 8886315931 D2B0542Y 8886316041 D1L1697Y D2B0543Y 8886316361 D1E0506Y 8886318541 D1J1639Y D1M2717Y D1M2851Y 8886318641 D1M2844Y D2A0933Y D2E0947Y D2E1925Y 8886321251 D2E3008Y 8886322641 D2A0451Y 8886328021 D1D0290Y 8886328031 D1L0721Y D1L2169Y D2B2861Y 8886330971 D2D2188Y 8886336931 D2B2738Y D2E0660Y D2F0767Y 8886339351 D1M0107Y D1M1299Y CD3123K D2B2213Y
Recalling Firm/
Manufacturer		 Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information ContactMedtronic 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
ActionMedtronic 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 Commerce40152 units
DistributionUS 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 CycleTPLC 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) Database510(K)s with Product Code = GAT
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