Health product recall

ChemoClave and ChemoLock Vial Spikes (2019-02-22)

Starting date:
February 22, 2019
Posting date:
March 18, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69340

Affected Products

  1. ChemoClave Vial Spike
  2. ChemoLock Vial Spike

Reason

ICU Medical identified the potential for plastic burr particulate in certain lots of ChemoLock and ChemoClave Vial Spikes, originating from the protective cap used in the assembly of the device.

Affected products

A. ChemoClave Vial Spike

Lot or serial number
  • 3839690
  • 3873006
Model or catalog number
  • CH-80S
Companies
Manufacturer

ICU Medical Inc.

951 Calle Amanecer

San Clemente

92673

California

UNITED STATES

B. ChemoLock Vial Spike

Lot or serial number
  • 3853997
  • 3853999
  • 3854004
  • 3854005
  • 3866764
  • 3866769
  • 3866770
  • 3872085
  • 3932908
Model or catalog number
  • CL-80S
  • CL-80S-10
  • CL-80S-5
Companies
Manufacturer

ICU Medical Inc.

951 Calle Amanecer

San Clemente

92673

California

UNITED STATES