Date Initiated by Firm |
June 11, 2018 |
Date Posted |
July 13, 2018 |
Recall Status1 |
Terminated 3 on March 13, 2019 |
Recall Number |
Z-2440-2018 |
Recall Event ID |
80374 |
510(K)Number |
K100700
|
Product Classification |
Tube, feeding - Product Code FPD
|
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. |
Code Information |
Lot #135137 |
Recalling Firm/ Manufacturer |
Canadian Hospital Specialties 2760 Brighton Rd Oakville Canada
|
Manufacturer Reason for Recall |
The product may be packaged with the incorrect length of feeding tube as labeled.
|
FDA Determined Cause 2 |
Process control |
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. |
Quantity in Commerce |
10/10-tube cases |
Distribution |
Distribution was made to GA. The foreign recalling firm also distributed product to Canada. |
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.
|