FDA recall Z-2089-2023

Product

Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

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-2089-2023