MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
FDA device recall Z-1547-2025 · posted 2025-04-09 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 020 units
- Distribution
- US Nationwide distribution
- Date initiated
- 2025-03-05
- Date posted
- 2025-04-09
- Location
- Northfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REPROCESSED ELECTROSURGICAL ELECTRODES (K012669) | Surgical Instruments Service and Savings, Inc. | 2002-06-27 |