HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
Reported: December 21, 2022 Initiated: November 2, 2022 #Z-0522-2023
Product Description
HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
Reason for Recall
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Details
- Recalling Firm
- Stradis Medical, LLC dba Stradis Healthcare
- Units Affected
- 144 units
- Distribution
- US nationwide distribution, and Canada.
- Location
- Peachtree Corners, GA
Frequently Asked Questions
What product was recalled? ▼
HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891. Recalled by Stradis Medical, LLC dba Stradis Healthcare. Units affected: 144 units.
Why was this product recalled? ▼
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 21, 2022. Severity: Moderate. Recall number: Z-0522-2023.
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