Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Reported: January 18, 2023 Initiated: December 15, 2022 #Z-0933-2023
Product Description
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Reason for Recall
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Details
- Recalling Firm
- Stradis Healthcare
- Units Affected
- 1,040 units
- Distribution
- US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.. Recalled by Stradis Healthcare. Units affected: 1,040 units.
Why was this product recalled? ▼
Potential for the outer bag having pinhole leaks near the seal, 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 January 18, 2023. Severity: Moderate. Recall number: Z-0933-2023.
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