Date Initiated by Firm |
December 01, 2018 |
Create Date |
January 11, 2019 |
Recall Status1 |
Terminated 3 on April 02, 2021 |
Recall Number |
Z-0725-2019 |
Recall Event ID |
81763 |
510(K)Number |
K100700
|
Product Classification |
Tube, feeding - Product Code FPD
|
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.
|
Code Information |
Lot 139457 |
Recalling Firm/ Manufacturer |
Canadian Hospital Specialties 2760 Brighton Rd Oakville Canada
|
For Additional Information Contact |
905-825-9300
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
The firm notified its consignees of the recall by email on 12/01/2018. The letter identified the affected product, problem and actions to be taken. The firm requested return of the product. |
Quantity in Commerce |
75 cases of 10 |
Distribution |
US in the states of TN |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FPD and Original Applicant = BENLAN, INC.
|