FDA recall Z-1246-2024

Product

DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.

Reason for recall

The sterile blister packaging may be damaged, and sterility may be compromised.

Distribution

Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.

Key facts

Status

Ongoing

Initiation date

2024-01-09

Report date

2024-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1246-2024