Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Reported: January 18, 2023 Initiated: December 15, 2022 #Z-0944-2023
Product Description
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
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
- 80 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? ▼
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.. Recalled by Stradis Healthcare. Units affected: 80 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-0944-2023.
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