| Class 2 Device Recall DRIVELINE MANAGEMENT TRAY | |
Date Initiated by Firm | July 01, 2019 |
Create Date | August 06, 2019 |
Recall Status1 |
Terminated 3 on June 26, 2020 |
Recall Number | Z-2169-2019 |
Recall Event ID |
83329 |
Product Classification |
Dressing change tray - Product Code OXQ
|
Product | DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population. |
Code Information |
Lot # 2019022690 Exp: 8/31/2020 |
Recalling Firm/ Manufacturer |
Centurion Medical Products Corporation 100 Centurion Way Williamston MI 48895-9086
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For Additional Information Contact | Lisa A. Carpenter 517-546-5400 Ext. 1156 |
Manufacturer Reason for Recall | Potential for sterile packaging to be compromised |
FDA Determined Cause 2 | Employee error |
Action | 1) Please identify all inventory that you have within your possession and segregate the recalled product.
2) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of this record, your response will be documented, and a Centurion Representative will contact you regarding retrieval of the product from your facility, if required.
3) Please forward a copy of this notice to any facilities to whom this product may have been further distributed.
Please contact the number for any question (517) 546-5400 Ext.1122. |
Quantity in Commerce | 1900 each |
Distribution | US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI. |
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.
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