Presource Kits containing the Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, Tubing, and LogiCal Kits (2021-04-13)
- Starting date:
- April 13, 2021
- Posting date:
- April 22, 2021
- 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-75445
Last updated:
2021-04-22
Affected Products
A. STRL ANGIOGRAPHY KIT M20268
B. MANIFOLD KIT M20858 CATH LAB
C. INTERVENTIONAL RADIOLOGY PACK
Reason
Smiths Medical has initiated a medical device recall for Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, Tubing, and Logical Kits due to specific lots potentially being manufactured with insufficient or incomplete welds. Cardinal Health presource uses these products in the manufacturing and kitting process for select custom sterile kits, listed above.
Affected products
A. STRL ANGIOGRAPHY KIT M20268
Lot or serial number
479977
495964
544532
574809
Model or catalog number
SAN30LHUAA
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
B. MANIFOLD KIT M20858 CATH LAB
Lot or serial number
562538
564769
569494
Model or catalog number
SAN30AGJGA
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
C. INTERVENTIONAL RADIOLOGY PACK
Lot or serial number
516012
Model or catalog number
SAN30ITRVA
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES