The Recall Desk
HighFDA (Devices)·Z-2079-2015·Announced 2015-07-22

Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

Sorin Group USA is recalling 28 Sorin Stockert Heater-Cooler 3T devices due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (Mycobacteria) and a medical device where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Sorin Group USA, Inc. is recalling 28 units of the Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz. These devices are used for temperature control during extracorporeal perfusion of durations up to 6 hours. The affected units have serial numbers ranging from 16S11455 to 16S15190 and product code 16-02-83.

The recall is issued because of the potential colonization of organisms, including Mycobacteria, in the devices. This risk exists if proper disinfection and maintenance are not performed according to the Instructions for Use. The agency has classified this recall as Class II.

The devices were distributed nationwide in the United States and internationally to numerous countries, including AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, and ZA. Users should ensure the devices are properly disinfected and maintained per the Instructions for Use to prevent potential colonization.

The recalled product

Product
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Manufacturer
Sorin Group USA, Inc.
Category
Medical Device — Perfusion Equipment
Hazard
Affected units
28

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product code 16-02-83 Serial number 16S11455-16S15190

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Sorin Group USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Sorin Group USA, Inc.

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Same hazard · mycobacteria

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