Drug recall
2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Item No. 46098-79 The…
FDA recall event 75491 · Class II · ICU Medical, Inc.
Key facts
| Event ID | 75491 |
|---|---|
| Recall numbers | Z-0414-2017, Z-0415-2017, Z-0416-2017, Z-0417-2017, Z-0418-2017, Z-0419-2017, Z-0420-2017, Z-0421-2017, Z-0422-2017, Z-0423-2017, Z-0424-2017, Z-0425-2017 and 150 more |
| Recalling firm | ICU Medical, Inc. |
| Product type | Devices |
| Products | 2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Item No. 46098-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure…, 4 PORT "OFF" MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS, Item No. 46098-78 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer…, 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…, 5 Port "OFF" Manifold w/TRANSPAC¿ IV, Item No. 46100-29 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…, ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that… and 155 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Initiation date | Sep 27, 2016 |
| Report date | Nov 23, 2016 |
| Termination date | Jul 11, 2017 |
| City | San Clemente |
| State | CA |
| Country | United States |
| FEI number | 2025816 |
At a glance
- 100–999 Products in this recall
- 1–9 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: