| Class 2 Device Recall Medline |  |
Date Initiated by Firm | October 15, 2024 |
Date Posted | November 25, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0532-2025 |
Recall Event ID |
95638 |
Product Classification |
Cardiovascular procedure kit - Product Code OEZ
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Product | (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and
(2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile. |
Code Information |
(1) REF CDS840132O - Lot number 24BBF701, exp. 10/31/2024, UDI-DI each 10195327245276, UDI-DI case 40195327245277;
(2) REF DYNJ903016G - Lot numbers 24DBP801, exp. 8/31/2025; and 24CBJ749, exp. 11/30/2024, UDI-DI each - 10195327657154, UDI-DI case - 40195327657155. |
Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
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Manufacturer Reason for Recall | Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | The recalling firm issued letters on and dated 10/15/2024 via email and first-class mail explaining the issue, potential risk, and informing the consignee stickers are to be provided upon request to be placed onto the Medline pack instructing that the affected component is to be removed and replaced with an item in inventory. Required actions were included which were to (1) Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately; (2) Use the link and information in the letter to complete the response form. List the quantity of affected product in inventory on the form. Upon receipt of the submitted response form, the consignee will receive over-labels to place on affected inventory with instructions for the consignee staff to remove the affected component prior to using the kit. The labels will be provided via FedEx overnight; (4) If the consignee is a distributor or has resold or transferred this product to another company or individual, the consignee is to notify them of the recall communication. |
Quantity in Commerce | 408 kits |
Distribution | US Nationwide distribution in the states of AL, GA, MA, NJ, and PA. |
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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