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TRANSPAC MONITORING KITS (2016-09-27)
- Starting date:
- September 27, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60676
Affected Products
A. TRANSPAC IV MONITORING KIT W/4 WAY STOPCOCK, 3 WAY STOPCOCK AND 24" ARTERIAL PRESSURE TUBING
B. TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (POLE MOU
C. TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH 3 ML SQUEEZE FLUSH DEVICE
D. TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH
E. TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS
Reason
ICU Medical Inc. has identified a potential leak with certain monitoring kits that contain the TRANSPAC IV TRANDUCERS. A small number of these devices may have potential leak or potentially introduce small amounts of air into the line.
Affected products
A. TRANSPAC IV MONITORING KIT W/4 WAY STOPCOCK, 3 WAY STOPCOCK AND 24" ARTERIAL PRESSURE TUBING
Lot or serial number
135645
Model or catalog number
42594-05
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
B. TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (POLE MOU
Lot or serial number
3249806
Model or catalog number
42641-06
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
C. TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH 3 ML SQUEEZE FLUSH DEVICE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
011-46101-92
011-46104-41
42583-05
42584-05
42585-05
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
D. TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH
Lot or serial number
3247898
3261651
3292882
Model or catalog number
42587-05
42590-05
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
E. TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES