Device product
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Z-1193-2018
Product summary
- Firm
- Teleflex Medical
- Event
- Event 79301
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-1193-2018
Official wording
Reason: Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.
Code information: Lot Number 73H1600207
Distribution pattern: KS
Derived failure modes
-
Unknown
Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.