MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R
This recall is currently active, issued April 9, 2025. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- March 5, 2025
- Posted
- April 9, 2025
- Recall Number
- Z-1546-2025
- Quantity
- 738 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Distribution
US Nationwide distribution
Lot / Code Info
UDI/DI 10888277395350, Lot Numbers: 513468, 513993, 514445, 514446, 514449, 515558, 515650, 515861, 515907, 516476, 516478, 516549, 517320, 517321, 517322, 517323, 517358, 517360, 517627, 517628, 517631, 518473, 518476, 518477, 518960, 519256, 519257, 519258, 519260, 519264, 519265, 519678, 519759, 519760, 519762, 519860, 519965, 519967, 520279, 520357, 520358, 520691, 520692, 521358, 521359, 522140, 522141, 522142, 522143, 522506, 522507, 522508, 522510, 524010, 524011, 524015, 524798, 524801, 524802, 524822, 525470, 525474, 527114, 527117, 528453, 528455, 528583, 528585, 528586, 528896, 528899, 528902, 528903, 528904, 529481, 529491, 529931, 529932, 530010, 530435, 531018, 531025, 531026, 531027, 531672, 532270, 532272, 532815, 532817, 532819, 532822.
Root Cause
Under Investigation by firm
Action Taken
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.