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Various ICU Medical Inc. Devices (2017-08-01)
- Starting date:
- August 1, 2017
- Posting date:
- September 5, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-64418
Affected Products
A. 100" (254 Cm) 20 Drop Y-Type Blood Set W/200 Micron Filter, Hand Pump, 2 Clave, Rotating Luer W/Filter Cap
B. Y-Type Blood Set W/170 Micron Filter, Hand Pump, Clave, Rotating Luer
C. 164"(417cm) 20 Drop Y-Type Blood Admin Set W/200 Micron Filter, Hand Pump, 4 Gang 4-Way Stopcocks W/Baseplate, 4 Microclave Clear, Rotating Luer, 1Ext
Reason
Some devices were labelled "does not contain DEHP" even though the product may potentially contain small amounts of DEHP. The company has not received complaints or reports of any patient injury associated with this mislabelling.
Affected products
A. 100" (254 Cm) 20 Drop Y-Type Blood Set W/200 Micron Filter, Hand Pump, 2 Clave, Rotating Luer W/Filter Cap
Lot or serial number
- 3332425
- 3364299
- 3396263
Model or catalog number
K098-001
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
B. Y-Type Blood Set W/170 Micron Filter, Hand Pump, Clave, Rotating Luer
Lot or serial number
- 3332396
- 3343695
- 3347144
- 3426308
Model or catalog number
- B9220
- B9405
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
C. 164"(417cm) 20 Drop Y-Type Blood Admin Set W/200 Micron Filter, Hand Pump, 4 Gang 4-Way Stopcocks W/Baseplate, 4 Microclave Clear, Rotating Luer, 1Ext
Lot or serial number
- 3332863
- 3344272
- 3356773
- 3367490
- 3371297
- 3389253
Model or catalog number
MC33481
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES