STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
Reported: December 21, 2022 Initiated: November 2, 2022 #Z-0544-2023
Product Description
STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
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
- 100 units
- Distribution
- US nationwide distribution, and Canada.
- Location
- Peachtree Corners, GA
Frequently Asked Questions
What product was recalled? ▼
STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,. Recalled by Stradis Medical, LLC dba Stradis Healthcare. Units affected: 100 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-0544-2023.
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