Spinning Spiros (2020-08-28)
- Starting date:
- August 28, 2020
- Posting date:
- September 25, 2020
- 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-74015
Last updated:
2020-09-25
Affected Products
- Droop Admin Set
- CLAVE EXT. SET
- Spiros Extension / Add-On Set
- 4-Way Stopcock W/Clave, Vial Adapter
- Spinning Spiros Closed Male Luer
- Microclave Ext Set
- Chemolock Admin Set
- Chemolock
Reason
The potential for certain lots of the Spinning Spiros to exhibit small amounts of leaks due to manufacturing variability has been identified. The non-spinning version is not affected.
Affected products
A. Droop Admin Set
Lot or serial number
- 4749745
- 4764622
- 4790769
- 4799897
- 4865663
- 4901210
Model or catalog number
- 20124-01
- CL3962
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
B. CLAVE EXT. SET
Lot or serial number
- 4603209
- 4733428
- 4741183
- 4806862
- 4849120
- 4865839
- 4866030
- 4895024
Model or catalog number
- CH3034
- CH3762
- CH3763
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
C. Spiros Extension / Add-On Set
Lot or serial number
- 4774080
- 4790739
Model or catalog number
CH3354
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
D. 4-Way Stopcock W/Clave, Vial Adapter
Lot or serial number
- 4774269
- 4777289
- 4849437
Model or catalog number
K7052-001
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
E. Spinning Spiros Closed Male Luer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 20130-01
- CH2000S
- CH2000S-C
- K7040-001
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
F. Microclave Ext Set
Lot or serial number
4742641
Model or catalog number
CL3932
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
G. Chemolock Admin Set
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- CL3020
- CL3951
- CL3999
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
H. Chemolock
Lot or serial number
- 4787230
- 4867947
Model or catalog number
CL-35
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES