ChemoClave and ChemoLock Vial Spikes (2019-02-22)
- Starting date:
- February 22, 2019
- Posting date:
- March 18, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69340
Affected Products
- ChemoClave Vial Spike
- ChemoLock Vial Spike
Reason
ICU Medical identified the potential for plastic burr particulate in certain lots of ChemoLock and ChemoClave Vial Spikes, originating from the protective cap used in the assembly of the device.
Affected products
A. ChemoClave Vial Spike
Lot or serial number
- 3839690
- 3873006
Model or catalog number
- CH-80S
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
B. ChemoLock Vial Spike
Lot or serial number
- 3853997
- 3853999
- 3854004
- 3854005
- 3866764
- 3866769
- 3866770
- 3872085
- 3932908
Model or catalog number
- CL-80S
- CL-80S-10
- CL-80S-5
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES