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Health product recall

PRESSURE INJECTABLE PICC KIT AND PICC SELDINGER CONVERSION SET (2015-08-12)

Starting date:
August 12, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-55748

Affected Products

  1. PRESSURE INJECTABLE PICC KIT
  2. PICC SELDINGER CONVERSION SET

Reason

There is the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.

Affected products

A. PRESSURE INJECTABLE PICC KIT

Lot or serial number

All lots

Model or catalog number
  • ASK-04041-AC
  • CA-05041-HP
  • CA-05041-HPX
  • CA-05052-HP
  • CA-05052-HPX
  • EU-04041-HPMSB
  • EU-05041-HPMSB
  • EU-05052-HPMSB
  • EU-05541-HPMSB
Companies
Manufacturer
Arrow International Inc.
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

B. PICC SELDINGER CONVERSION SET

Lot or serial number

All lots

Model or catalog number

PI-01451-LS

Companies
Manufacturer
Arrow International Inc.
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES