regard recall: Sterility Concern
regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the…
Why was regard recalled?
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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?
Lot numbers 21706, 22052C, and 22405.
- Product
- regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the…
- Recalling firm
- Resource Optimization & Innovation Llc
- Quantity
- 388 kits
- Distribution
- Distribution was made to LA, MS, and TX.
- Recall date
- October 14, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)