SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical recall
SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds…
Why was SUTURE REMOVAL KIT CUSTOMED 100/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?
Catalog number: 900010 Lots: 141015851 exp. 10/31/2015 150116710 exp.1/31/2016 150117001 exp.2/28/2016 150317560 exp.3/31/2016 150317560 exp.3/31/2016 150418252 exp.5/31/2016 150418252 exp.5/31/2016 150518605 exp.5/31/2016 150518605 exp.5/31/2016
- Product
- SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds…
- Recalling firm
- Customed, Inc
- Quantity
- 20200 kits
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)