OPEN HEART PACK 1/CS Used by medical staff to perform recall
OPEN HEART PACK 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…
Why was OPEN HEART PACK 1/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:9002618 Lots: 140915325 exp. 10/31/15 141015615 exp. 11/30/15 141216324 exp. 12/31/15 150418448 exp. 5/31/16 150116558 exp. 5/31/16 150116558 exp. 5/31/16 150418449 exp. 5/31/16
- Product
- OPEN HEART PACK 1/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
- 27
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)