Device 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
Z-0595-2016
Product summary
- Firm
- Benlan, Inc.
- Event
- Event 72851
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 units
- Official record key
device-enforcement:Z-0595-2016
Official wording
Reason: The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.
Code information: Lots 114842, 116433 & 118251
Distribution pattern: Worldwide Distribution - US including GA & Internationally to Canada.
Derived failure modes
-
Unknown
The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.