Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Reported: January 18, 2023 Initiated: December 15, 2022 #Z-0931-2023
Product Description
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
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
- 920 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 Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile. Recalled by Stradis Healthcare. Units affected: 920 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-0931-2023.
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