Device product
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Z-0732-2016
Product summary
- Event
- Event 73007
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1008 boxes
- Official record key
device-enforcement:Z-0732-2016
Official wording
Reason: Damage to package seals potentially compromising sterility.
Code information: Lot# G154341 Exp: 4/14/18
Distribution pattern: Distributed US (nationwide) and in Canada.
Derived failure modes
-
Unknown
Damage to package seals potentially compromising sterility.