Health product recall

SPIROS CLOSED MALE LUER (2021-03-12)

Starting date:
March 12, 2021
Posting date:
October 1, 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-76551

Last updated: 2021-10-01

Affected Products

  1. CLAVE EXT. SET
  2. SPIROS CLOSED MALE LUER
  3. SPINNING SPIROS CLOSED MALE LUER

Reason

ICU medical has identified the potential for certain lots of spiros to exhibit small amounts of leaks due to a molding defect. The leak occurs when the spiros is not activated and prior to connecting to a patient's intravenous administration set. This issue pertains to both spinning and non-spinning spiros and was discovered through internal testing.

Affected products

A. CLAVE EXT. SET

Lot or serial number
  • 5125297
  • 5135759
Model or catalog number
  • CH3011
  • CH3762
Companies
Manufacturer
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES

B. SPIROS CLOSED MALE LUER

Lot or serial number
  • 5141416
Model or catalog number
  • 20120-01
Companies
Manufacturer
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES

C. SPINNING SPIROS CLOSED MALE LUER

Lot or serial number
  • 5125300
  • 5135765
  • 5142935
Model or catalog number
  • 20130-01
  • K7040-001
Companies
Manufacturer
ICU Medical Inc.
951 Calle Amanecer
San Clemente
92673
California
UNITED STATES

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