| Class 2 Device Recall Medline procedure kits |  |
Date Initiated by Firm | October 16, 2024 |
Date Posted | November 22, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0511-2025 |
Recall Event ID |
95615 |
Product Classification |
Nerve block tray - Product Code OGJ
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Product | MEDLINE procedure kits labeled as follows:
1) ECHOSTIM BLOCK SET, REF DYNJRA9043S;
2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A |
Code Information |
Codes:
1) DYNJRA9043S, UDI/DI 10193489888287(each) 40193489888288(case), Lot Numbers: 23CBE390, 23CBO216, 23EBM309, 23EBP979, 23EBS281, 23GBV099, 23HBG915, 23IBG610, 23IBG611, 23JBQ712, 23KBC341;
2) PAIN1622A, UDI/DI 10193489891690 (each) 40193489891691 (case), Lot Numbers: 21ELA821, 21GLA615, 21KLA308, 22ALA608, 22CLA681, 22ELB088, 22FLB075, 22GLA543, 22KLA019, 23BLA333, 23DLA466, 23HLA896
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Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
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For Additional Information Contact | Haley Barclay 866-359-1704 |
Manufacturer Reason for Recall | The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | An IMMEDIATE ACTION REQUIRED RECALL notification letter dated 10/16/24 was sent to customers.
REQUIRED ACTION:
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.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.
3.Upon receipt of your submitted response form, your account will receive over-labels to place unaffected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-216-FGRecall Code:
4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
Quantity in Commerce | 3396 units |
Distribution | US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands |
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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