Date Initiated by Firm |
November 22, 2017 |
Create Date |
March 29, 2018 |
Recall Status1 |
Terminated 3 on July 11, 2018 |
Recall Number |
Z-1271-2018 |
Recall Event ID |
79445 |
510(K)Number |
K132177
|
Product Classification |
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
|
Product |
8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter |
Code Information |
Lot/Serial/Model/Catalog Numbers/Exp. Date: Lot # MJKK420; serial # N/A, Catalog # MRDP80PLN, Exp. Date 2022-01-09; UDI#- 884908110449 |
Recalling Firm/ Manufacturer |
Medical Components, Inc dba MedComp 1499 Delp Dr Harleysville PA 19438-2936
|
For Additional Information Contact |
215-256-4201
|
Manufacturer Reason for Recall |
The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
|
FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
Recall notification was issued, by mail to the customers on November 22, 2017. This notification requested that customers review inventory and return all un-used affected product after quarantine. Questions or concerns can be directed to 215-256-4201/ |
Quantity in Commerce |
24 Eaches |
Distribution |
CA, AR. AL |
Total Product Life Cycle |
TPLC Device Report
|
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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 = LJT and Original Applicant = MEDCOMP (MEDICAL COMPONENTS)
|