MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and
FDA device recall Z-2440-2018 · posted 2018-07-13 · Terminated
Recall details
- Recalling firm
- Canadian Hospital Specialties
- Reason for recall
- The product may be packaged with the incorrect length of feeding tube as labeled.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPD
- Quantity affected
- 10/10-tube cases
- Distribution
- Distribution was made to GA. The foreign recalling firm also distributed product to Canada.
- Date initiated
- 2018-06-11
- Date posted
- 2018-07-13
- Date terminated
- 2019-03-13
- Location
- Oakville, Canada
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (K100700) | Benlan, Inc. | 2010-12-13 |