DOUBLE SWIVEL Catheter System (2019-07-22)
- Starting date:
- July 22, 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-70593
Last updated: 2019-08-02
Affected Products
A. DOUBLE SWIVEL ELBOW 15M - DOUBLE FLIP TOP CAP WITH SEAL -22M/15F
B. SUPERSET DOUBLE SWIVEL CATHETER MOUNT 22F - DOUBLE FLIP TOP CAP - 22M/15F
C. FLEXIBLE DOUBLE SWIVEL CATHETER MOUNT 22F - DOUBLE FLIP TOP CAP WITH SEAL - 22M/15F
Reason
Since March 2019 there have been 17 complaints about cracked ports in swivel elbows where the port cap is inserted.
Affected products
A. DOUBLE SWIVEL ELBOW 15M - DOUBLE FLIP TOP CAP WITH SEAL -22M/15F
Lot or serial number
2183345
2190292
Model or catalog number
1898000
Companies
- Manufacturer
-
Intersurgical Ltd.
Crane House, Molly Millars Lane
Wokingham, Berkshire
RG41 2RZ
UNITED KINGDOM
B. SUPERSET DOUBLE SWIVEL CATHETER MOUNT 22F - DOUBLE FLIP TOP CAP - 22M/15F
Lot or serial number
2181825
2182119
Model or catalog number
3521000
Companies
- Manufacturer
-
Intersurgical Ltd.
Crane House, Molly Millars Lane
Wokingham, Berkshire
RG41 2RZ
UNITED KINGDOM
C. FLEXIBLE DOUBLE SWIVEL CATHETER MOUNT 22F - DOUBLE FLIP TOP CAP WITH SEAL - 22M/15F
Lot or serial number
2182403
Model or catalog number
3505000
Companies
- Manufacturer
-
Intersurgical Ltd.
Crane House, Molly Millars Lane
Wokingham, Berkshire
RG41 2RZ
UNITED KINGDOM