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