PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: July 12, 2023 Initiated: May 30, 2023 #Z-2089-2023

Product Description

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.

Details

Recalling Firm
DeRoyal Industries Inc
Units Affected
3 packs
Distribution
US Nationwide distribution.
Location
Powell, TN

Frequently Asked Questions

What product was recalled?
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219. Recalled by DeRoyal Industries Inc. Units affected: 3 packs.
Why was this product recalled?
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 12, 2023. Severity: Moderate. Recall number: Z-2089-2023.