FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by recall
FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing…
Why was FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by recalled?
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Code:9001127 Lots: 150115092 exp. 1/31/16 150115092 exp. 1/31/16 150217549 exp. 2/28/16 150317666 exp. 4/30/16 150317666 exp. 4/30/16 150317666 exp. 4/30/16 150317667 exp. 4/30/16 150418282 exp. 4/30/16 150418282 exp. 4/30/16 150418282 exp. 4/30/16
- Product
- FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing…
- Recalling firm
- Customed, Inc
- Quantity
- 1960 kits
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)