Recall Z-0725-2019— Canadian Hospital Specialties
Class II · Terminated
Class II FDA medical device recall by Canadian Hospital Specialties, initiated 2018-12-01, terminated 2021-04-02. It names one FDA 510(k) clearance: K100700. Product: MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.. Reason: The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled..
- Recalling firm
- Canadian Hospital Specialties
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-01
- Terminated
- 2021-04-02
- Firm location
- Oakville, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.
Reason for recall
The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.