FDA Medical Device Recalls (openFDA)
Canadian Hospital Specialties: MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.
- Recall number
- Z-2440-2018
- Recalling firm
- Canadian Hospital Specialties
- Product
- MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.
- Status
- Terminated
- Initiated
- 2018-06-11
- Posted
- 2018-07-13
- Terminated
- 2019-03-13
- Reason
- The product may be packaged with the incorrect length of feeding tube as labeled.
- Root cause
- Process control
- Action
- The recalling firm issued a letter dated 6/1/2018 via email on 6/11/2018 to formally notify their customer of the reason for recall, discontinue distribution of the product, and complete the enclosed Product Recall Response Form for return via email.
- Quantity
- 10/10-tube cases
- Distribution
- Distribution was made to GA. The foreign recalling firm also distributed product to Canada.
- Lot, serial or model codes
- Lot #135137
- 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