Z-2535-2015 Class II Terminated
FDA device recall Z-2535-2015 was initiated by Covidien LLC on Aug 6, 2015 and is designated Class II. Reason for recall: Sterility may be compromised The recall status is terminated (terminated Jun 29, 2017). Affected quantity: 569 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 9, 2015
- Initiation Date
- Aug 6, 2015
- Termination Date
- Jun 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 569 kits
Product Description
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Reason for Recall
Sterility may be compromised
Distribution Pattern
US Nationwide Distribution
Code Information
Lot Numbers: 1504700146
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2535-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026