| Class 2 Device Recall Medline | |
Date Initiated by Firm | March 22, 2024 |
Date Posted | August 22, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2697-2024 |
Recall Event ID |
94356 |
Product Classification |
Bottle, collection, vacuum - Product Code KDQ
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Product | 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926 |
Code Information |
UDI/DI 40888277422279 (package), 0888277DC265NSKX (unit), Lot Numbers: 670220512, 670220609, 670220621, 670220629, 670220712, 670220803, 670220815, 670220914, 670221009 |
Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
|
For Additional Information Contact | Karin Johnson 886-359-1704 |
Manufacturer Reason for Recall | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees. |
Quantity in Commerce | 88703 units |
Distribution | Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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