PS-500 Scope Warmer recall: Sterility Concern
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Why was PS-500 Scope Warmer recalled?
Damage to package seals potentially compromising 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# G154341 Exp: 4/14/18
- Product
- PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
- Recalling firm
- JosNoe Medical, Inc.
- Quantity
- 1008 boxes
- Distribution
- Distributed US (nationwide) and in Canada.
- Recall date
- February 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)