FDA recall Z-1383-2022

Product

AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

Reason for recall

Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.

Distribution

United States: TX and AK

Key facts

Status

Terminated

Initiation date

2019-09-25

Report date

2022-07-20

Termination date

2024-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1383-2022