Recall Z-0844-2024— Covidien LP

Name: FDA recall Z-0844-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-21

Class II · Ongoing

Class II FDA medical device recall by Covidien LP, initiated 2023-12-21. It names one FDA 510(k) clearance: K981582. Product: Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT. Reason: Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level..

Recalling firm: Covidien LP
Classification: Class II
Status: Ongoing
Initiated: 2023-12-21
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K981582 — SURGILON, DERMALON, & OPHTHALONDavis & Geck, Inc.·cleared 1998-07-13

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

Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT

Reason for recall

Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

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