Date Initiated by Firm |
May 13, 2016 |
Create Date |
June 08, 2016 |
Recall Status1 |
Terminated 3 on March 22, 2019 |
Recall Number |
Z-1935-2016 |
Recall Event ID |
74225 |
510(K)Number |
K120868
|
Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
|
Product |
MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿
MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿
MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿
MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK¿ & APA |
Code Information |
(PN 0684-00-0294-01U) (PN 0684-00-0294-02U) (PN 0684-00-0295-01U) (PN 0684-00-0295-02U) (PN 0684-00-0296-01U) |
Recalling Firm/ Manufacturer |
Datascope Corporation 15 Law Dr Fairfield NJ 07004-0011
|
For Additional Information Contact |
Customer Service 973-244-6100
|
Manufacturer Reason for Recall |
It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).
|
FDA Determined Cause 2 |
Unknown/Undetermined by firm |
Action |
Maquet Inc sent an Urgent Medical Device Field Correction Letter/Response Form dated 5/13/2016 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. |
Quantity in Commerce |
31,030 units (US); 15,604 units (OUS) |
Distribution |
Worldwide Distribution. |
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 = DSP and Original Applicant = DATASCOPE CORP., CARDIAC ASSIST DIVISION
|