—#213130

Product

MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K012669
Affected lot / code info: UDI/DI 10080196415106, Lot Numbers: 506549, 508766, 509420, 512036, 512983, 514060, 514709, 516475, 516802, 517626, 518478, 518961, 519248, 519259, 519411, 519412, 519413, 519966, 519969, 520277, 522144, 522145, 527110, 527112, 528454, 528458, 528584, 531021, 531022.

Why it was recalled

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline issued a "Medline ReNewal IMMEDIATE ACTION REQUIRED" notice dated 3/5/2025, to its consignees on 03/05/2025 via USPS first class mail. The notice explained the issue, potential risk, and requested the following actions: REQUIRED ACTION: 1. Immediately check your stock for the affected item numbers and the affected lot numbers. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Upon receipt of your submitted response form, FedEx return label(s) will be provided. Even if you do not have any affected product, please complete and return the form, as indicated on the response form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline ReNewal. For questions, please contact 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 distribution

Timeline

Recall initiated: 2025-03-05
Posted by FDA: 2025-04-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213130. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.