SPIROS CLOSED MALE LUER (2021-03-12)
- Starting date:
- March 12, 2021
- Posting date:
- October 1, 2021
- 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-76551
Last updated:
2021-10-01
Affected Products
- CLAVE EXT. SET
- SPIROS CLOSED MALE LUER
- SPINNING SPIROS CLOSED MALE LUER
Reason
ICU medical has identified the potential for certain lots of spiros to exhibit small amounts of leaks due to a molding defect. The leak occurs when the spiros is not activated and prior to connecting to a patient's intravenous administration set. This issue pertains to both spinning and non-spinning spiros and was discovered through internal testing.
Affected products
A. CLAVE EXT. SET
Lot or serial number
- 5125297
- 5135759
Model or catalog number
- CH3011
- CH3762
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
B. SPIROS CLOSED MALE LUER
Lot or serial number
- 5141416
Model or catalog number
- 20120-01
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
C. SPINNING SPIROS CLOSED MALE LUER
Lot or serial number
- 5125300
- 5135765
- 5142935
Model or catalog number
- 20130-01
- K7040-001
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES