Health product recall

SafeStep Huber Needle Set & PowerLoc MAX Power-Injectable Infusion Set (2020-06-19)

Starting date:
June 19, 2020
Posting date:
July 17, 2020
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-73549

Last updated: 2020-07-17

Affected Products

  1. SafeStep Huber Needle Set
  2. PowerLoc MAX Power-Injectable Infusion Set
  3. PowerLoc MAX Power-Injectable Infusion Set

Reason

It has been identified that the product catalog and lot numbers referenced in Attachment A may develop cracks or breaks in the tubing near the Luer or Y site of the device during use.

Affected products

A. SafeStep Huber Needle Set

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • LH-0029
  • LH-0029YN
  • LH-0030
  • LH-0030YN
  • LH-0031
  • LH-0031YN
  • LH-0032
  • LH-0032YN
  • LH-0033
  • LH-0033YN
Companies
Manufacturer
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES