Drug recall
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
FDA recall event 84722 · Class II · TELEFLEX MEDICAL INC
Key facts
| Event ID | 84722 |
|---|---|
| Recall numbers | Z-1269-2020, Z-1270-2020 |
| Recalling firm | TELEFLEX MEDICAL INC |
| Product type | Devices |
| Products | Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440, Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed. |
| Initiation date | Jan 13, 2020 |
| Report date | Feb 26, 2020 |
| Termination date | Nov 24, 2021 |
| City | Morrisville |
| State | NC |
| Country | United States |
| FEI number | 3005747797 |
At a glance
- 1–9 Products in this recall
- 10–99 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: