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WECK
TELEFLEX INCORPORATED · Model IPN028494 · UDI-DI 34026704631798
GDT
Prescription
10
510(k) clearances
4,743
Adverse events (2 deaths)
5
Recalls
104
Facilities
Description
VISISTAT 35W NON-STERILE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-02-15 | Teleflex Medical | 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. |
| 2017-03-24 | Teleflex Medical | Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device. |
| 2016-11-18 | Teleflex Medical | Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2014-10-08 | Customed, Inc | Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.