Drug recall
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be…
FDA recall event 72539 · Class II · Baylis Medical Corp *
Key facts
| Event ID | 72539 |
|---|---|
| Recall numbers | Z-0356-2016 |
| Recalling firm | Baylis Medical Corp * |
| Product type | Devices |
| Products | ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Microcatheter may have circumferential defects (cracks) along its shaft. |
| Initiation date | Oct 28, 2015 |
| Report date | Dec 9, 2015 |
| Termination date | Nov 17, 2016 |
| City | Montreal |
| Country | Canada |
| FEI number | 3005241199 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: