Drug recall
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl…
FDA recall event 69658 · Class II · Teleflex Medical
Key facts
| Event ID | 69658 |
|---|---|
| Recall numbers | Z-0504-2015, Z-0505-2015 |
| Recalling firm | Teleflex Medical |
| Product type | Devices |
| Products | Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428…, Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor. |
| Initiation date | Sep 3, 2014 |
| Report date | Dec 10, 2014 |
| Termination date | Aug 14, 2017 |
| City | Durham |
| 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: