Shoulder Pack recall: Sterility Concern
Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds…
Why was Shoulder Pack recalled?
Significant 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 140312139 140412663 140513136 140613731
- Product
- Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds…
- Recalling firm
- Customed, Inc
- Quantity
- 96
- Distribution
- US Distribution to Florida, New York and Puerto Rico..
- Recall date
- December 10, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)