STOCKERT Heater-Cooler System 3T, 230 V

FDA device recall Z-2771-2017 · posted 2017-07-25 · Terminated

Recall details

Recalling firm

Sorin Group USA, Inc.

Reason for recall

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.

Action taken

"Consignees were sent a recall notification, dated 06/30/2017, via mail. Instructions included a recommendation from LivaNova to use its oxygenators, or other oxygenators that are equipped with compatible heat exchangers, to ensure that the permeability rate is within the prescribed allowable limits (ALs). Depending on whether or not the oxygenator was from LivaNova, there were specific instructions to follow for each type and source. Consignees were also instructed to complete and return the Confirmation Form. If product was further distributed, the firm asks that further customers be notified of the recall and that customers contact the LivaNova Quality Assurance Team at usfsn@livanova.com. Questions regarding the recall can be directed to 800-986-4702 or 3T.US@livanova.com. Any adverse reactions are to be reported to FDA's MedWatch Adverse Event Reporting program."

Root cause

Device Design

Status

Terminated

Product code

DWC

Quantity affected

7,546 units total

Distribution

"Domestic: 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, W

Date initiated

2017-06-30

Date posted

2017-07-25

Date terminated

2023-10-10

Location

Arvada, CO

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