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:

Affected Products

  1. CATH RADIAL SHSC-LF
  2. 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