Laparoscopy Pack recall: Sterility Concern
Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
Why was Laparoscopy Pack 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 140513052 140513243 140613806 140714400
- Product
- Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
- Recalling firm
- Customed, Inc
- Quantity
- 1152
- Distribution
- US Distribution to Florida, New York and Puerto Rico..
- Recall date
- December 10, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)