FDA recall Z-2090-2023

Product

Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183

Reason for recall

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-05-30

Report date

2023-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2090-2023