Health product recall

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