FDA recall Z-2088-2023

Product

Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478

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-2088-2023