Health product recall

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