FDA recall Z-1300-2020

Product

Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201

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-1300-2020