Flexima APDL Drainage Catheter System and Kit recall: Sterility Concern
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking…
Why was Flexima APDL Drainage Catheter System and Kit recalled?
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
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) GTIN/UDI 0871472932347, Lot # 33540319, Exp. 03/01/2027; b) GTIN/UDI 0871472932348, Lot # 33471466, Exp. 02/21/2027
- Product
- Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 89 units
- Distribution
- US, Colombia, Philippines, Russia
- Recall date
- September 25, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)