Recall Z-1193-2018— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2018-02-15, terminated 2018-10-31. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-15
- Terminated
- 2018-10-31
- Firm location
- Research Triangle Park, NC, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.