SHOULDER PACK 6/CS Used by medical staff to perform recall
SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…
Why was SHOULDER PACK 6/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:9002616 Lots: 141015729 exp. 10/31/15 141216309 exp. 12/31/15 150116557 exp. 2/28/16 150317941 exp. 3/31/16 150317942 exp. 3/31/16 150317943 exp. 4/30/16 150418380 exp. 5/31/16 150317945 exp. 5/31/16 150317944 exp. 5/31/16 150418381 exp. 5/31/16 150418379 exp. 5/31/16 150317946 exp. 6/30/16
- Product
- SHOULDER PACK 6/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
- 413
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)