Health product recall

NeoMed Enteral Feeding Tubes with Enteral Only Connectors (2018-06-04)

Starting date:
June 4, 2018
Posting date:
June 14, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67040

Affected products

NeoMed Enteral Feeding Tubes with Enteral Only Connectors

Reason

This recall was initiated due to the potential for the tethered plug on the hub inadvertently opening after closure. This problem affects only certain production lots. As described in the Instructions for Use provided with the product, when the tube is flushed with sterile water before and after use, Neomed has determined that the patient risk resulting from an open hub is extremely low. No adverse events related to this issue have been reported to Neomed.

Affected products

NeoMed Enteral Feeding Tubes with Enteral Only Connectors

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • FTL5.0P-EO
  • FTL6.5P-EO
  • FTL8.0P-EO
  • FTM8.0P-EO
  • FTS5.0P-EO
  • FTS6.5P-EO
  • FTS8.0P-EO
  • PFTL6.5P-EO
  • PFTM6.5P-EO
  • PFTM8.0P-EO
Companies
Manufacturer
NeoMed Inc.
100 Londonderry Court, Suite 112
Woodstock
30188
Georgia
UNITED STATES