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