Non-Filtered Curlin IV Administration Sets with Spikes (2017-12-14)

Starting date:
December 14, 2017
Posting date:
January 8, 2018
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-65554

Affected Products

A. NON-DEHP MICROBORE ADMINISTRATION SET
B. MICROBORE ADMINISTRATION SET

Reason

Complaints were received regarding particulate found on the tip of some Non-Filtered Curlin IV Spike Sets. The loose particulate was located on the external edge of the non-vented spike. There are no sterility issues. No adverse events have been reported.

Affected products

A. NON-DEHP MICROBORE ADMINISTRATION SET

Lot or serial number

CF1515305
CF1519505
CF1519506
CF1522501
CF1523004
CF1530704
CF1601204
CF1604701
CF1605403
CF1609005
CF1611001

Model or catalog number

340-4166
340-4168

Companies
Manufacturer
Zevex Inc.
also trading as Moog Medical Devices Group
4314 Zevex Park Lane
Salt Lake City
84123
UNITED STATES

B. MICROBORE ADMINISTRATION SET

Lot or serial number

CF1518301
CF1521104
CF1522307
CF1523803
CF1524407
CF1526506
CF1528603
CF1534902
CF1603304
CF1613101
CF1615209

Model or catalog number

340-4114
340-4134

Companies
Manufacturer
Zevex Inc.
also trading as Moog Medical Devices Group
4314 Zevex Park Lane
Salt Lake City
84123
UNITED STATES