Regard recall
Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
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?
026403B Exp Date 2017-07-13; 029909B Exp Date 2017-12-08; 031012B Exp Date 2018-01-18; 031963B Exp Date 2018-03-01;
- Product
- Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
- Recalling firm
- Resource Optimization & Innovation Llc
- Quantity
- 236 kits
- Distribution
- US Distribution to LA and TX.
- Recall date
- April 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)