Medtronic Perfusion Systems: Medical Device Recall in 2015 - (Recall #: Z-2736-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 18, 2015

Date Posted: September 16, 2015

Recall Number: Z-2736-2015

Event ID: 72025

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.

Status: Terminated

Product Quantity: Total 1594 (1306 US, 288 OUS)

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated