| Class 2 Device Recall MEDRX POLYURETHANE FEEDING TUBE | |
Date Initiated by Firm | July 16, 2019 |
Create Date | August 15, 2019 |
Recall Status1 |
Completed |
Recall Number | Z-2281-2019 |
Recall Event ID |
83374 |
510(K)Number | K100700 |
Product Classification |
Tube, feeding - Product Code FPD
|
Product | MED-RX POLYURETHANE FEEDING TUBES:
a) 5Fr X 16" (40cm), REF 54-1650R
b) 6.5Fr X16" (40cm), REF 54-1665R
c) 5Fr X 24" (60cm), REF 54-2450R
d) 6.5Fr X 24" (60cm), REF 54-2465R
e) 8Fr X 24: (60cm), REF 54-2480R
f) 8Fr X 36" (91cm), REF 54-3680R |
Code Information |
a) 5Fr X 16" (40cm), REF 54-1650R, Lot Number 141487 b) 6.5Fr X16" (40cm), REF 54-1665R, Lot Number 141863 c) 5Fr X 24" (60cm), REF 54-2450R, Lot Numbers: 142844, 143130 d) 6.5Fr X 24" (60cm), REF 54-2465R, Lot Number 142843 e) 8Fr X 24: (60cm), REF 54-2480R, Lot Number 142870 f) 8Fr X 36" (91cm), REF 54-3680R, Lot Number 142842 |
Recalling Firm/ Manufacturer |
Canadian Hospital Specialties 2760 Brighton Rd Oakville Canada
|
Manufacturer Reason for Recall | The firm received a complaint that the connector detached from the feeding tube. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm initiated the recall by email on 07/16/2019. The notice requested the consignee cease distribution/use of the product, complete and return the product recall response form to arrange for product return and replacement/credit. |
Quantity in Commerce | 2870 units |
Distribution | GA and 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.
|
510(K) Database | 510(K)s with Product Code = FPD
|
|
|
|