FDAClass IISeptember 9, 2015

HIGADO Y PANCREA 2/CS Used by medical staff to perform recall

HIGADO Y PANCREA 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…

Why was HIGADO Y PANCREA 2/CS Used by medical staff to perform 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:9001966 Lots: 141015750 exp. 11/30/15 140814976 exp. 10/31/15 141216318 exp. 1/31/16 150317708 exp. 4/30/16 150317709 exp. 4/30/16 150418331 exp. 4/30/16 150418332 exp. 4/30/16

Product
HIGADO Y PANCREA 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
Recalling firm
Customed, Inc
Quantity
248
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