FDA Recall Terminated

DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Recall: Z-2169-2019 · Initiated July 1, 2019

Recall

Recall Number
Z-2169-2019
Event Number
83329
Firm
Centurion Medical Products Corporation
FEI Number
3008403546
Product Code
OXQ
Status
Terminated
Root Cause
Employee error
Initiated
July 1, 2019
Terminated
June 26, 2020
Address
100 Centurion Way, Williamston, MI, 48895-9086

Description

DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Reason

Potential for sterile packaging to be compromised

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.

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.

Quantity

1900 each