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Health product recall

ENTERALITE INFINITY ENTERAL FEEDING SETS (2015-12-01)

Starting date:
December 1, 2015
Posting date:
January 14, 2016
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-56600

Affected Products

A. ENTERALITE INFINITY BAG SET
B. Enteralite Infinity Spike Set

Reason

The manufacturer has become aware of an increase in the number of complaints for EnterLite Infinity Enteral Pump Delivery sets with ENFit connector system and transitional stepped connectors (administration sets) that are used with the EnteraLite Infinity Enteral Feeding Pump.  Customers are reporting formula leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.

Affected products

A. ENTERALITE INFINITY BAG SET

Lot or serial number

All lots.

Model or catalog number
  • INF0500-A
  • INF0500-A
  • INF1200-A
  • INF1200-A
Companies
Manufacturer
Zevex Inc.
also trading as Moog Medical Devices Group
4314 Zevex Park Lane
Salt Lake City
84123
Utah
UNITED STATES

B. Enteralite Infinity Spike Set

Lot or serial number

All lots.

Model or catalog number
  • INF0020-A
  • INF0020-A
Companies
Manufacturer
Zevex Inc.
also trading as Moog Medical Devices Group
4314 Zevex Park Lane
Salt Lake City
84123
Utah
UNITED STATES