Z-2735-2015 Class II Terminated
FDA device recall Z-2735-2015 was initiated by Medtronic Perfusion Systems on Aug 18, 2015 and is designated Class II. Reason for recall: Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone… The recall status is terminated (terminated May 9, 2016). Affected quantity: 1594 total (1306 US, 288 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 16, 2015
- Initiation Date
- Aug 18, 2015
- Termination Date
- May 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1594 total (1306 US, 288 OUS)
Product Description
MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
Reason for Recall
Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.
Distribution Pattern
Worldwide Distribution-US (nationwide) including the states of AL, AR, CA, CO, FL, HI, ID, IN, KS, LA, MA, MS, MO, NY, NJ, OH, PA, TN, TX, UT, and WI, and the countries of Bolivia, Denmark, Dominican Republic, Italy, Latvia, Lebanon, Mexico, Panama, Singapore, Venezuela, and Zambia.
Code Information
759625A 759884A 759491A 762355A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2735-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026