Stopcocks Clear, Four-Way Stopcock, Double Luer Lock Adapter, and Stopcock, Clear 1-Way w/ Male Luer Lock (2018-11-04)
- Starting date:
- November 4, 2018
- Posting date:
- November 30, 2018
- 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-68476
Affected products
A. Stopcocks Clear, Four-Way Stopcock
B. Double Luer Lock Adapter
C. Stopcock, Clear 1-Way w/ Male Luer Lock
Reason
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their pouched product. Because of damage to a packaging die there is a possibility that the seal formed on the edge of the pouch may be incomplete for some product, which could result in a loss of sterility to the affected product. As precautionary measure argon is pulling back all product packaged with that die to prevent the inadvertent use of a potentially non-sterile device.
Affected products
A. Stopcocks Clear, Four-Way Stopcock
Lot or serial number
11226656
11228887
Model or catalog number
041210002A
Companies
- Manufacturer
-
Argon Medical Devices Inc.
1445 Flat Creek Road
Athens
75751
Texas
UNITED STATES
B. Double Luer Lock Adapter
Lot or serial number
11231393
Model or catalog number
040184000A
Companies
- Manufacturer
-
Argon Medical Devices Inc.
1445 Flat Creek Road
Athens
75751
Texas
UNITED STATES
C. Stopcock, Clear 1-Way w/ Male Luer Lock
Lot or serial number
11226187
11227967
11229619
Model or catalog number
041216000A
Companies
- Manufacturer
-
Argon Medical Devices Inc.
1445 Flat Creek Road
Athens
75751
Texas
UNITED STATES