Recall Z-2088-2023— DeRoyal Industries Inc

Name: FDA recall Z-2088-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-30

Class II · Ongoing

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2023-05-30. FDA's recall record names no specific 510(k) clearance for this event. 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: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-05-30
Firm location: Powell, TN, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.