Recall Z-0595-2016 ยท FPD Tube, Feeding
Benlan, Inc.
MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada
| Date | Dec 11, 2015 |
| Status | Terminated |
| Reason | The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size. |
| Root cause | Under Investigation by firm |
| Action | Benlan, Inc. sent a Product Recall Notification letter dated December 11, 2015, to all affected customers. Customers were asked to examine their stock and to discontinue/use of the product and return product. The letter included a response form which was to be returned via fax to 905-825-9600. Customers with questions were instructed to call 905-825-9300. |
| Quantity | 120 units |
| Distribution | Worldwide Distribution - US including GA & Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100700 | MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES Benlan, Inc., Dec 13, 2010 |