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Surgilon recallZ-1178-2023 · Covidien, LP · initiated Dec 2, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-1178-2023
Status
Open, Classified
Initiated by the company
Dec 2, 2022
Posted by the FDA
Feb 25, 2023
Recalling firm
Covidien, LP
Quantity
87708 units
Product code
GAR
FDA submissions
K981582
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

Product description

Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT 88861932-51 SURGILON* 2-0 BLK 75CM GS10 88861971-71 SURGILON* 1 BLK 75CM GS21 88861985-71 SURGILON* 1 BLK 75CM SC1X36 SBS-1884G SURGILON* 4-0 WHI 45CM P12X12 SBS-1928G SURGILON* 5-0 BLK 45CM P13X12

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

GTIN: 20884521073996, 20884521076652, 10884521072183, 20884521072180, 10884521071223, 20884521071220, 10884521071797, 20884521071794, 20884521071763, 20884521071787, 20884521071749, 10884521073838, 20884521073835, 20884521076669, 10884521076662, 10884521071766, 20884521071725, 10884521071513, 20884521071510. Model Number Lot # 8886188351 D1K1677FY 8886191571 D2C3242Y 8886191931 D2B2243Y 8886191941 D1M2553Y D1M2561Y D2B0169Y 8886191951 D1M0915Y D2A0560Y D2B1245Y D2B1537Y D2B2751Y D2C0267Y D2C0907Y D2C1101Y D2D2347Y D2D2437Y D2D2506Y D2D2510Y D2E0905Y 8886191961 D1M1423Y D2A0861Y D2A0865Y D2A1709Y D2B1349Y D2B1350Y D2B2727Y 8886191971 D1M0640Y D1M1494Y D2C0962Y 8886193251 D1G1867Y 8886197171 D2B0290Y D2B0445Y D2B0476Y 8886198571 D1E0626Y SBS1884G D1E1212FY SBS1928G D2B0707FY D2C3247FY

Devices named in this recall

12 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

37 devices cleared under K981582 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91324).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page