Date Initiated by Firm |
October 23, 2014 |
Date Posted |
April 03, 2015 |
Recall Status1 |
Terminated 3 on August 13, 2015 |
Recall Number |
Z-1379-2015 |
Recall Event ID |
70690 |
510(K)Number |
K083842 K101533
|
Product Classification |
System, multipurpose for in vitro coagulation studies - Product Code JPA
|
Product |
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH. |
Code Information |
Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06. |
Recalling Firm/ Manufacturer |
TEM Systems Inc 4309 Emperor Blvd Ste 100 Durham NC 27703-8069
|
For Additional Information Contact |
Rick Epps 919-941-7777 Ext. 108
|
Manufacturer Reason for Recall |
Some of vials were found to be partially filled.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Tem sent an Dear Customer letter dated October 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
You are entitled to return products delivered to you in the event that they are defective or otherwise not in conformity with your order when you received them. If you observe a low level of diluent in a box of Rotrol P lot number 41819801 at your location, please contact us for a free of charge replacement box from a new lot of Rotrol P.
You can reach us at:
Email: support@roteminc.com
Phone: 919-941-7777, Option 2
Toll Free: 1-866-597-1652, Option 2
We apologize for any inconvenience you may experience. |
Quantity in Commerce |
Total 1574 x 5 vials per box |
Distribution |
Nationwide 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 = JPA and Original Applicant = PENTAPHARM GMBH 510(K)s with Product Code = JPA and Original Applicant = Tem Innovations GmbH
|