Z-2736-2015 Class II Terminated
FDA device recall Z-2736-2015 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: Total 1594 (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
- Total 1594 (1306 US, 288 OUS)
Product Description
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B. 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
209050007 209087876 209107465 209135076 209162502 209195930 209241496 209241613 209270018 209270092 209297994 209298091 209298094 209310403 209326025 209373545 209388464 209396017 209401269 209401312 209415313 209431890 209464644 209512240 209556873 209621268 209644548 209653827
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2736-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026