Recall Z-1546-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated March 5, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R
Codes / lots: 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.
Reason for recall
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
FDA-determined 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.
Details
- Recall number
- Z-1546-2025
- Initiated
- March 5, 2025
- Posted by FDA
- April 9, 2025
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 738 units
- Distribution
- US Nationwide distribution
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1547-2025 Class II | MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number…Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline… | 03/05/2025Open, Classified |
| Z-1548-2025 Class II | MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline…Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline… | 03/05/2025Open, Classified |
| Z-1549-2025 Class II | MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue)…Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline… | 03/05/2025Open, Classified |