Recall Z-2601-2018— Covidien LLC

Name: FDA recall Z-2601-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-15

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2018-06-15, terminated 2019-05-08. It names one FDA 510(k) clearance: K981935. Product: Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955. Reason: Potential proplylene glycol contamination.

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2018-06-15
Terminated: 2019-05-08
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K981935 — POLYSORB SUTUREUnited States Surgical, A Division of Tyco Healthc·cleared 1998-06-25

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 1 36" 90 cm Undyed GS-21, Product Number CL-955

Reason for recall

Potential proplylene glycol contamination

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