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Class 2 Device Recall Medline Pill Splitters |
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Date Initiated by Firm |
May 11, 2022 |
Create Date |
June 24, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1287-2022 |
Recall Event ID |
90196 |
Product Classification |
Pill crusher/cutter - Product Code OHY
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Product |
Medline Pill Splitters; 1 each/box; 144 boxes/carton |
Code Information |
Model Number: NON135000; UDI/DI:8019673489; Lot Numbers: 50920060001, 50920080001, 50920110001, 50921030001, 50921040001, 50921050001, 50921060001, 50921080001, 50921090001, 50921100001, 50921110001, 50921120001, 50922020001 |
Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
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For Additional Information Contact |
Karin Johnson 224-931-1071
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Manufacturer Reason for Recall |
Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade.
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FDA Determined Cause 2 |
Process change control |
Action |
The firm issued a recall notice to consignees on 05/11/2022 via mail. The letter instructs the consignee to check their stock, destroy affected product, and return the response form. On 5/16/2022, the firm sent out an updated recall notice. |
Quantity in Commerce |
840,087 each |
Distribution |
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Panama, and Hongkong. |
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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