FDAClass IDecember 10, 2014

Skin Staple Removal recall: Sterility Concern

Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…

Why was Skin Staple Removal recalled?

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

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?

Lot numbers: 111112954 111112965 111123297 111123444 112010204 112020511 112030694 112051651 112052014 112083064 112093637 112104287 112114538 112124884 113025834 113026068 113036743 113047031 113057506 113067936 113067964 140111127 140312184 140513161 140613781 140814822 1130688891

Product
Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
Recalling firm
Customed, Inc
Quantity
20960
Distribution
US Distribution to Florida, New York and Puerto Rico..
Recall date
December 10, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls