Custom OR Procedure Packs containing Smiths Medical LogiCal Kits (2021-04-12)
- Starting date:
- April 29, 2021
- Posting date:
- April 29, 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-75491
Last updated:
2021-04-29
Affected Products
- CATH RADIAL SHSC-LF
- CARDIAC CATH SHSC-LF
Reason
Medline is recalling custom procedure packs containing Smiths Medical LogiCal Kits, part no. M20553. Smiths Medical became aware that specific lots of Medex LogiCal Kits, may have been manufactured with insufficient or incomplete welds. These devices may fail to perform as intended during use due to an insufficient or incomplete weld.
Affected products
A. CATH RADIAL SHSC-LF
Lot or serial number
20LBS078
21ABG315
21ABK163
21BBN231
21CBF483
Model or catalog number
DYNJ46787C
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
B. CARDIAC CATH SHSC-LF
Lot or serial number
20HBJ202
20JBF537
20KBG028
20LBI370
21ABQ302
21ABQ956
Model or catalog number
DYNJ46788C
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES