FDAClass IISeptember 9, 2015

FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff recall

FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture…

Why was FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff 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:9001139 Lots: 150117003 exp. 2/28/16 150317668 exp. 4/30/16 150317669 exp. 5/31/16

Product
FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture…
Recalling firm
Customed, Inc
Quantity
280 kits
Distribution
Distributed Only in Puerto Rico.
Recall date
September 9, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls