FDA recall Z-1275-2020

Covidien LLC · Class II · device

Product

Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - 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.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2019-12-18
Report date
2020-02-26
Termination date
2022-08-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1275-2020