Recall Z-1277-2020— Covidien LLC

Name: FDA recall Z-1277-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-18

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2019-12-18, terminated 2022-08-16. It names one FDA 510(k) clearance: K000037. Product: Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.. Reason: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots..

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2019-12-18
Terminated: 2022-08-16
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K000037 — MONOFILAMENT BIOSYN SUTUREUnited States Surgical, A Division of Tyco Healthc·cleared 2000-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.