Stradis Healthcare Foley Catheter Insertion Tray with recall: Sterility Concern
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Why was Stradis Healthcare Foley Catheter Insertion Tray with recalled?
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660; b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466
- Product
- Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
- Recalling firm
- Stradis Healthcare
- Quantity
- 920 units
- Distribution
- US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
- Recall date
- January 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)