FDA recall Z-1692-2023

DeRoyal Industries Inc · Class II · device

Product

Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.

Reason for recall

The custom procedure packs contain light handle covers that have been recalled by another firm.

Distribution

US Nationwide distribution in the state of VA.

Key facts

Status
Ongoing
Initiation date
2023-04-17
Report date
2023-06-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1692-2023