MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
FDA Recall Z-1548-2025 · Posted 2025-04-09
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Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2025-03-05
Product Quantity315 units
Reason for Recall
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
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 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 [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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