Z-1193-2018 Class II Terminated
FDA device recall Z-1193-2018 was initiated by Teleflex Medical on Feb 15, 2018 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Oct 31, 2018). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 4, 2018
- Initiation Date
- Feb 15, 2018
- Termination Date
- Oct 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Reason for Recall
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.
Distribution Pattern
KS
Code Information
Lot Number 73H1600207
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1193-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026