TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical recall
TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture…
Why was TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical 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:900110 Lots: 140915149 exp. 1/31/16 140915149 exp. 1/31/16 150217119 exp. 2/28/16 150217119 exp. 2/28/16 150217228 exp. 4/30/16 150217228 exp. 4/30/16 150217228 exp. 4/30/16 150318049 exp. 6/30/16 150318049 exp. 6/30/16 150518601 exp. 6/30/16 150518601 exp. 6/30/16 150619116 exp. 6/30/16 150619116 exp. 6/30/16
- Product
- TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture…
- Recalling firm
- Customed, Inc
- Quantity
- 3550 kits
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)