EAR PACK 3/CS Used by medical staff to perform surgical recall
EAR PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…
Why was EAR PACK 3/CS Used by medical staff to perform surgical 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:9002234 Lots: 141015704 exp. 12/31/15 141216300 exp. 12/31/15 140915246 exp. 12/31/15 150217385 exp. 2/28/16 150317727 exp. 4/30/16 150418353 exp. 4/30/16 150418353 exp. 4/30/16 150518688 exp. 5/31/16 150619252 exp. 6/30/16
- Product
- EAR PACK 3/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
- 48
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)