PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff recall
PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture…
Why was PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff 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:9001297 Lots: 141015609 exp. 10/31/15 141115976 exp. 11/30/15 150116757 exp. 2/28/16 150116758 exp. 2/28/16 150116756 exp. 2/28/16 150619380 exp. 6/30/16
- Product
- PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture…
- Recalling firm
- Customed, Inc
- Quantity
- 390 packs
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)