FDA Device recall Z-2774-2017
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
- FDA Device
- Class II
- terminated
- Published 2017-08-02
On 2017-08-02 the FDA classified a Class II recall of STOCKERT Heater-Cooler System 3T, 127V/60 Hz by Sorin Group Usa, citing plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceed….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2774-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-30 |
| Published | 2017-08-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sorin Group Usa |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
Reason
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
Identifiers
| code_info | Item No. 16-02-83; Serial No. 16S11455-16S16509 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2774-2017%22
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