FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by recall
FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing…
Why was FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 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:900150PKC Lots: 141115955 exp. 12/31/15 150217440 exp. 2/28/16 150619462 exp. 6/30/16
- Product
- FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing…
- Recalling firm
- Customed, Inc
- Quantity
- 160
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)