Date Initiated by Firm |
January 21, 2020 |
Date Posted |
February 11, 2020 |
Recall Status1 |
Terminated 3 on January 12, 2023 |
Recall Number |
Z-1357-2020 |
Recall Event ID |
84908 |
Product Classification |
Orthopedic tray - Product Code OJH
|
Product |
Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180 |
Code Information |
REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180 |
Recalling Firm/ Manufacturer |
Medline Industries Inc Three Lakes Drive Northfield IL 60093
|
For Additional Information Contact |
Kassandra Cotner 866-359-1704
|
Manufacturer Reason for Recall |
The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Consignees were notified by telephone on 01/21/2020 followed by an e-mail on 01/22/2020 and 02/05/2020 that included a formal recall letter with response form. The recall letter identified the affected product and requested the user to quarantine the product for subsequent pick up by Medline Industries Inc. Consignee was asked to complete and return Recall Response form. |
Quantity in Commerce |
122 |
Distribution |
California only. No governmental, Canadian or Mexican consignees.
TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108
HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162
OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS PKWY ONTARIO CA 917645103 |
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.
|