Date Initiated by Firm | June 06, 2022 |
Create Date | July 27, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1473-2022 |
Recall Event ID |
90516 |
Product Classification |
laparoscopy kit - Product Code FDE
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Product | Brand Name: Medline
Product Name: convenience kits labeled as: LAP CHOLE
Model/Catalog Number: DYNJ907150 |
Code Information |
Lot Code: 21FBJ077, 21GBJ337, 21GBJ338
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Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - SPT 1170 S Northpoint Blvd Waukegan IL 60085-6757
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For Additional Information Contact | Kassandra Cotner 866-775-6072 |
Manufacturer Reason for Recall | Kits contain leaking bottles of isopropyl alcohol |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations. |
Quantity in Commerce | 54 units |
Distribution | US Nationwide distribution. |
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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