Recall Z-1547-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
| Date | Apr 9, 2025 (initiated Mar 5, 2025) |
| Status | Open, Classified |
| Reason | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 020 units |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012669 | REPROCESSED ELECTROSURGICAL ELECTRODES Surgical Instruments Service and Savings, Inc., Jun 27, 2002 |