FDAClass IISeptember 9, 2015

FANFOLD DRAPE 44"X58 60/CS Used by medical staff to recall

FANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…

Why was FANFOLD DRAPE 44"X58 60/CS Used by medical staff to 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:900633 Lots: 150116617 exp. 1/31/16 150116618 exp. 1/31/16 150116619 exp. 1/31/16 150116987 exp. 1/31/16 150217430 exp. 2/28/16 150217431 exp. 2/28/16 150318010 exp. 4/30/16 150318010 exp. 4/30/16 150318012 exp. 4/30/16 141216356 exp. 4/30/16 150318011 exp. 4/30/16

Product
FANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
Recalling firm
Customed, Inc
Quantity
3180
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