Regard recall
Regard, Item Number: 800401002, Sterile, GS0470B - Lap 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?
034435B Exp Date 2018-6-21; 037051B Exp Date 2018-6-21; 037462B Exp Date 2018-07-29; 038293B Exp Date 2018-08-17; 038779B Exp Date 2018-09-21; 039465B Exp Date 2018-10-10; 040093B Exp Date 2018-11-09;
- Product
- Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn
- Recalling firm
- Resource Optimization & Innovation Llc
- Quantity
- 3,000 kits
- Distribution
- US Distribution to LA and TX.
- Recall date
- April 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)