FDAClass IISeptember 9, 2015

ANGIODRAPE PK 4/CS Used by medical staff to perform recall

ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…

Why was ANGIODRAPE PK 4/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?

Catalog number: 900002 Lots: 140714427 exp. 7/30/2017 141014965 exp. 7/30/2017 150116709 exp. 1/31/2016 150318103 exp. 3/31/2016 150418510 exp. 4/30/2016 150519016 exp. 5/31/2016

Product
ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…
Recalling firm
Customed, Inc
Quantity
192 packs
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