Device product
Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Z-2062-2017
Product summary
- Event
- Event 77023
- Status
- Terminated
- Classification
- Class II
- Quantity
- 293,867 units total
- Official record key
device-enforcement:Z-2062-2017
Official wording
Reason: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Code information: UB32602, UB32593, UB32514, UB32521, UB32579, UB32573, UB32599, UB32614, UB32616, UB32533
Distribution pattern: US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador
Derived failure modes
-
Foreign material or chemical contamination
glass particles