BASIC PACK W/OUT GOWN 11/CS Used by medical staff to recall
BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
Why was BASIC PACK W/OUT GOWN 11/CS Used by medical staff to 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:900345 Lots: 140814984 exp. 11/30/15 140915133 exp. 11/30/15 150116998 exp. 2/28/16 150116805 exp. 2/28/16 150418393 exp. 4/30/16 150518794 exp. 5/31/16
- Product
- BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
- Recalling firm
- Customed, Inc
- Quantity
- 77
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)