FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0595-2016
- Recalling firm
- Benlan, Inc.
- 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
- Status
- Terminated
- Initiated
- 2015-12-11
- Posted
- not on file
- Terminated
- 2016-10-31
- 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.
- Lot, serial or model codes
- Lots 114842, 116433 & 118251
- 510(k) numbers
- ["K100700"]
- PMA numbers
- not on file
- Product code
- FPD
- Firm FEI
- 3932
- Firm city
- Oakville
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28