—#210784

Product

MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Codes: 1) PAIN1423A UDI-DI: 10193489201826 (each) 40193489201827 (case), Lot Numbers: 22GLA530, 23BLA921, 23DLA373, 23GLA522, 23ILA136, 23JLB217, 23KLA008; 2) PAIN1470A UDI-DI: 10193489957365 (each) 40193489957366 (case), Lot Numbers: 21JLA366, 21JLA956, 21LLA271, 22CLA831, 22DLA301, 22DLB149, 22FLA103; 3) PAIN1644 UDI-DI: 10193489331141 (each) 40193489331142 (case), Lot Numbers: 22FLA985, 23CLA104

Why it was recalled

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

Timeline

Recall initiated: 2024-10-16
Posted by FDA: 2024-11-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210784. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.