Recall Z-2440-2018— Canadian Hospital Specialties
Class II · Terminated
Class II FDA medical device recall by Canadian Hospital Specialties, initiated 2018-06-11, terminated 2019-03-13. It names one FDA 510(k) clearance: K100700. 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.. Reason: The product may be packaged with the incorrect length of feeding tube as labeled..
- Recalling firm
- Canadian Hospital Specialties
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-11
- Terminated
- 2019-03-13
- 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, 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.
Reason for recall
The product may be packaged with the incorrect length of feeding tube as labeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.