This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
ICU Medical 3-Way Stopcocks (2017-08-31)
- Starting date:
- August 31, 2017
- Posting date:
- September 26, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64560
Affected Products
- 3-Way High Flow Stopcock W/Rotating Luer
- 3 Gang 3-Way Stopcocks W/Rotating Luer
- 32"(81 Cm) Transfer Set W/3-Way Stopcock, Clamp, Rotating Luer, Non-Dehp Tubing
Reason
ICU Medical Inc. has identified certain stopcocks that are incorporated in I.V sets may contain a metallic burr. Out of an abundance of caution, ICU Medical Inc. is voluntarily recalling the affected devices. The company has not received complaints or reports of any patient injury associated with this issue.
Affected products
A. 3-Way High Flow Stopcock W/Rotating Luer
Lot or serial number
- 3456237
- 3486340
Model or catalog number
- B4020
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
B. 3 Gang 3-Way Stopcocks W/Rotating Luer
Lot or serial number
- 3447427
Model or catalog number
- B4154
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES
C. 32"(81 Cm) Transfer Set W/3-Way Stopcock, Clamp, Rotating Luer, Non-Dehp Tubing
Lot or serial number
- 3465813
Model or catalog number
- B30243
Companies
- Manufacturer
-
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES