FDA Device recall Z-0595-2016
MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Co…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Co… by Benlan, citing the product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0595-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-11 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Benlan |
| Distribution | GA |
Product
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
Reason
The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.
Identifiers
| code_info | Lots 114842, 116433 & 118251 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0595-2016%22
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