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.
FDA Recall Z-2440-2018 · Posted 2018-07-13
Advertisement
Recalling FirmCanadian Hospital Specialties
Recall StatusTerminated
Product CodeFPD
Date Initiated2018-06-11
Date Terminated2019-03-13
Product Quantity10/10-tube cases
Reason for Recall
The product may be packaged with the incorrect length of feeding tube as labeled.
Firm 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.
Root Cause
Process control
Distribution Pattern
Distribution was made to GA. The foreign recalling firm also distributed product to Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement