FDA recall Z-2649-2023

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

Reason for recall

The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-05-23
Report date
2023-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2649-2023