Recall Z-0732-2016— JosNoe Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by JosNoe Medical, Inc., initiated 2015-12-01, terminated 2016-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.. Reason: Damage to package seals potentially compromising sterility..
- Recalling firm
- JosNoe Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-01
- Terminated
- 2016-03-22
- Firm location
- Chelsea, MI, United States
Product description
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Reason for recall
Damage to package seals potentially compromising sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.