—#179319

Product

Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

FDA product code: GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K000037
Affected lot / code info: Lot - A9J0384Y Expiration Date - 2024-08-31

Why it was recalled

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

On December 18, 2109, Medtronic issued Urgent Medical Device Recall and Return Form notices to customers via courier service. Customers were advised to take the following required actions: 1. Please immediately quarantine and discontinue use of the affected item code and lot listed within the notice. 2. Please return affected product as indicated within the notice. All unused products from the affected item codes and lots must be returned. 3. If you have distributed any of the Polysorb braided or Biosyn monofilament absorbable sutures listed on the recall notice, please promptly forward the information from the letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2019-12-18
Posted by FDA: 2020-02-19
Terminated: 2022-08-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179319. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.