Health product recall

NANOCLAVE EXT SET (2020-06-29)

Starting date:
June 29, 2020
Posting date:
November 27, 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-74399



Last updated:
2020-11-27

Affected Products

NANOCLAVE EXT SET

Reason

ICU Medical has identified the potential for a manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Affected products

NANOCLAVE EXT SET

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

A1001

A1003

A1061

A1062

A1067

A1102

A1171

A1185

AM3007

AM3016

AM6092

Companies
Manufacturer

ICU MEDICAL CANADA, INC

2600 BOUL. ALFRED-NOBEL, SUITE: 100

SAINT-LAURENT

H4S 0A9

Alberta

CANADA