FDAClass IISeptember 9, 2015

GENERAL MINOR PK 5/CS Used by medical staff to perform recall

GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…

Why was GENERAL MINOR PK 5/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:900787 Lots: 140915506 exp. 10/31/15 140915506 exp. 10/31/15 140915506 exp. 10/31/15 150116821 exp. 6/30/19 150116820 exp. 2/28/16 150116822 exp. 2/28/16 150116823 exp. 2/28/16 150317878 exp. 3/31/16 150317879 exp. 3/31/16 150317659 exp. 3/31/16 150317880 exp. 3/31/16 150317660 exp. 3/31/16 150317661 exp. 3/31/16 150418264 exp. 4/30/16

Product
GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
Recalling firm
Customed, Inc
Quantity
425
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