FDA Device recall Z-1193-2018
Teleflex MEDICAL WECK Visistat 35
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Teleflex MEDICAL WECK Visistat 35 by Teleflex Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1193-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-15 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Teleflex Medical |
| Distribution | KS |
Product
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
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.
Identifiers
| code_info | Lot Number 73H1600207 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1193-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.