Z-0450-2017Class II
TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO FLUSHES, MACRODRIP...
Abbott Medical / initiated 2016-09-27 / Terminated / root cause: design
ICU Medical, Inc. began a recall of TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42651-05 The Transpac... on . FDA classified it as Class II and gives the reason as "ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0450-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Abbott Medical
- Product
- TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42651-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
- Product code
- DRS Transducer, Blood-Pressure, Extravascular
- 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.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- ICU Medical sent an Urgent Medical Device Recall Notification letter dated September 27, 2016, to all affected customers to inform them of the expanded recall of the monitoring kits with Transpac IV transducers. Customers were informed of updated communications from August 10, 2016, when ICU Medical sent a communication indicating a potential leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. Based on continued evaluation, ICU Medical is expanding the notification to now include certain other monitoring kits that contain the Transpac IV transducers. A small number of these devices may have the potential to leak or potentially introduce small amounts of air into the line. Customers with questions were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 2, or e-mail the following address: [email protected]. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or e-mail to [email protected]. Customers with questions were instructed to call 866-829-9025.
- Quantity in commerce
- 60 units
- Distribution
- Nationwide Distribution
- Product codes and lots
- 3235504
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0414-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0415-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0416-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0417-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0418-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0419-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0420-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0421-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0422-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0423-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0424-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0425-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0426-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0427-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0428-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0429-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0430-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0431-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0432-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0433-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0434-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0435-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0436-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0437-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0438-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0439-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0440-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0441-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0442-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0443-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0444-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0445-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0446-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0447-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0448-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0449-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0450-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0451-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0452-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0453-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0454-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0455-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0456-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0457-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0458-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0459-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0460-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0461-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0462-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0463-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0464-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0465-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0466-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0467-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0468-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0469-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0470-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0471-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0472-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0473-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0474-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0475-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0476-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0477-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0478-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0479-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0480-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0481-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0482-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0483-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0484-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0485-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0486-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0487-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0488-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0489-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0490-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0491-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0492-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0493-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0494-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0495-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0496-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0497-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0498-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0499-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0500-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0501-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0502-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0503-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0504-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0505-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0506-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0507-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0508-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0509-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0510-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0511-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0512-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0513-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0514-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0515-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0516-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0517-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0518-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0519-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0520-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0521-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0522-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0523-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0524-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0525-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0526-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0527-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0528-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0529-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0530-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0531-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0532-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0533-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0534-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0535-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0536-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0537-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0538-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0539-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0540-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0541-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0542-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0543-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0544-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0545-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0546-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0547-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0548-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0549-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0550-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0551-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0552-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0553-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0554-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0555-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0556-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0557-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0558-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0559-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0560-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0561-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0562-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0563-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0564-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0565-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0566-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0567-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0568-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0569-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0570-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0571-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0572-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0573-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0574-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0575-2017 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.