Regard recall
Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
Why was Regard recalled?
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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?
027525B Exp Date 2017-08-14; 028915B Exp Date 2017-10-19; 030195B Exp Date 2017-12-21; 031255B Exp Date 2018-01-29; 032688B Exp Date 2017-09-30; 033330B Exp Date 2018-05-03
- Product
- Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
- Recalling firm
- Resource Optimization & Innovation Llc
- Quantity
- 2016 kits
- Distribution
- US Distribution to LA and TX.
- Recall date
- April 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)