Recall Z-2089-2023— DeRoyal Industries Inc
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) PELVIC EXAM TRAY, REF 89-6219. 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) 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.