Primary PLUM Set, SAPPHIRE Primary Set and SAPPHIRE Epidural Set (2019-07-19)
- Starting date:
- July 19, 2019
- Posting date:
- August 2, 2019
- 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-70613
Last updated: 2019-08-02
Affected Products
A. Primary PLUM Set, Yellow Striped Tubing, Distal Microbore Tubing, Filter, Secure Lock
B. SAPPHIRE Pimary Set
C. SAPPHIRE Epidural Set
Reason
ICU medical has received reports of small amounts of fluid leaking out of air vents on inline filters on Plum and Sapphire Microbore Infusion Sets.
Affected products
A. Primary PLUM Set, Yellow Striped Tubing, Distal Microbore Tubing, Filter, Secure Lock
Lot or serial number
925155H
Model or catalog number
149530489
Companies
- Manufacturer
-
ICU Medical Inc.
600 NORTH FIELD DRIVE
LAKE FOREST
60045
Illinois
UNITED STATES
B. SAPPHIRE Pimary Set
Lot or serial number
3843263
3849197
855645H
855935H
865495H
885415H
896135H
896195H
896625H
936605H
Model or catalog number
163350455
163620455
163830455
Companies
- Manufacturer
-
ICU Medical Inc.
600 NORTH FIELD DRIVE
LAKE FOREST
60045
Illinois
UNITED STATES
C. SAPPHIRE Epidural Set
Lot or serial number
896225H
916845H
925825H
948155H
Model or catalog number
163730455
Companies
- Manufacturer
-
ICU Medical Inc.
600 NORTH FIELD DRIVE
LAKE FOREST
60045
Illinois
UNITED STATES