Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Numbe...
FDA Device Recall #Z-1475-2020 — Class II — February 10, 2020
Recall Summary
| Recall Number | Z-1475-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 10, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Maquet Cardiovascular Us Sales, Llc |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 146 US |
Product Description
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Reason for Recall
Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water
Distribution Pattern
Nationwide Foreign: Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Iran, Ireland, Israel, Italy, Japan, Kenya, Lithuania, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom
Lot / Code Information
ITEM: 88-103: Serial Numbers: SEV0725124 SEV0745196 SEV0832057 SEV0832058 SEV0833080 SEV0833081 SEV0910147 SEV0912065 W50010582 W50010772 W50010773 W50010774 W50011211 W50011212 W50011809 W50011810 W50011811 W50012589 W50013228 W50013359 W50013362 W50013363 W50013983 W50013984 W50014009 W50014080 W50014081 W50014082 W50014338 W50014339 W50014340 W50014425 W50014426 W50015254 W50015255 W50015480 W50015782 W50015964 W50015965 W50015966 W50015967 W50015968 W50017020 W50017021 W50017773 W50017953 W50017954 W50018081 W50018082 W50018188 W50018936 W50018937 W50019170 W50019172 W50020826 W50020827 W50021010 W50021068 W50021080 W50021115 W50021137 W50021169 W50021223 W50021224 W50021225 W50021228 W50021229 W50021326 W50021478 W50021526 W50021527 W50021528 W50021690 W50021723 W50022115 W50022118 W50023119 W50023347 W50023431 W50023468 W50023682 W50023712 W50023723 W50023770 W50023800 W50023801 W50023901 W50023933 W50023963 W50023989 W50024559 W50024606 W50025054 W50025079 W50025083 W50025142 W50025170 W50025204 W50025250 W50026016 W50026072 W50026778 W50026815 W50026954 W50026978 W50026996 W50027987 W50028001 W50028317 W50028353 W50028695 W50028733 W50028854 W50029123 W50029171 W50029201 W50030086 W50030180 W50030184 W50030715 W50031399 W50031975 W50032013 W50032606 W50032634 W50032635 W50032713 W50032773 W50032877 W50032977 W50032978 W50033103 W50033133 W50033645 W50033842 W50033930 W50033998 W50034018 Item Number: 88-203: Serial Numbers: W50034751 W50035168 W50035183 W50035196 W50035635 W50035651 W50035687 W50035704 W50036689 W50036719 W50037076 UDI Code: 88-103 07340153700109; 88-203 07340153700116
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| Z-0632-2021 | Class II | HLS Set Advanced Model Name: BEQ-HLS 5050 USA; ... | Nov 20, 2020 |
| Z-0633-2021 | Class II | HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS ... | Nov 20, 2020 |
| Z-0443-2021 | Class II | Blood Monitoring Unit (BMU 40), model no. 70104... | Sep 30, 2020 |
| Z-0133-2021 | Class II | Yuno II Mobile Operating Table - Product Usage:... | Sep 24, 2020 |
| Z-0132-2021 | Class II | Yuno Mobile Operating Table - Product Usage: In... | Sep 24, 2020 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.