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