AVANOS MIC-KEY SF Gastrostomy Feeding Tube
FDA Device Recall #Z-2969-2020 — Class II — July 29, 2020
Recall Summary
| Recall Number | Z-2969-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 29, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Avanos Medical, Inc. |
| Location | Alpharetta, GA |
| Product Type | Devices |
| Quantity | 284 units |
Product Description
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Reason for Recall
Devices had cracked or detached from the feeding tube body
Distribution Pattern
US states: OK IL WI PA TX IL PA NJ OK LA OUS: Belgium
Lot / Code Information
REF Product Code: 7120-12-1.0; Size 12Fr, 1.0 cm; Lot # 30041194 REF Product Code: 7120-12-1.7; Size: 12Fr, 1.7 cm; Lot # 30039482 REF Product Code: 7120-12-4.5; Size: 12Fr, 4.5cm; Lot # 30057268 REF Product Code: 7120-14-0.8; Size:14Fr, 0.8cm; Lot # 30020939 REF Product Code: 7120-14-1.0; Size: 14Fr, 1.0cm; Lot # 30012320, 30020940 REF Product Code: 7120-14-1.2; Size: 14Fr, 1.2cm; Lot # 30020941, 30046143 REF Product Code: 7120-14-1.5; Size: 14Fr, 1.5cm; Lot # 30012322, 30027259 REF Product Code: 7120-14-1.7; Size: 14Fr, 1.7cm; Lot # 30012323 REF Product Code: 7120-14-2.0; Size:14Fr, 2.0cm; Lot # 30012326, 30018098 REF Product Code: 7120-14-2.3; Size: 14Fr, 2.3cm; Lot # 30018099 REF Product Code: 7120-14-2.5; Size: 14Fr, 2.5cm; Lot # 30012328 REF Product Code: 7120-14-2.7; Size: 14Fr, 2.7cm; Lot # 30012324 REF Product Code: 7120-14-3.0; Size: 14Fr, 3.0cm; Lot # 30012327 REF Product Code: 7120-14-3.5; Size: 14Fr, 3.5cm; Lot # 30041187 REF Product Code: 7120-16-5.5; Size: 16Fr, 5.5cm; Lot # 30046156 REF Product Code: 7140-12-1.5; Size: 12Fr, 1.5cm; Lot # 30015733 REF Product Code: 7140-14-0.8; Size: 14Fr, 0.8cm; Lot # 30020938 REF Product Code: 7140-14-1.0; Size: 14Fr, 1.0cm; Lot # 30072145, 30020061 REF Product Code: 7140-14-1.2; Size: 14Fr, 1.2cm; Lot # 30020062 REF Product Code: 7140-14-1.5; Size: 14Fr, 1.5cm; Lot # 30020063 REF Product Code: 7140-14-1.7; Size: 14Fr, 1.7cm; Lot # 30020064, 30049920 REF Product Code: 7140-14-2.0; Size: 14Fr, 2.0cm; Lot # 30020065 REF Product Code: 7140-14-2.3; Size: 14Fr, 2.0cm; Lot # 30020066 REF Product Code: 7140-14-2.5; Size: 14Fr, 2.5cm; Lot # 30020067 REF Product Code: 7140-14-3.5; Size: 14Fr, 3.5cm; Lot # 30021846 REF Product Code: 7140-14-4.0; Size: 14Fr, 4.0cm; Lot # 30021847 REF Product Code: 7140-14-4.5; Size: 14Fr, 4.5cm; Lot # 30021848 REF Product Code: 7140-14-5.0; Size: 14Fr, 5.0cm; Lot # 30044458 REF Product Code: 7140-16-1.0; Size: 16Fr, 1.0cm; Lot # 30058995 REF Product Code: 7140-16-1.5; Size: 16Fr, 1.5cm; Lot # 30021429 REF Product Code: 7140-16-2.3; Size: 16Fr, 2.3cm; Lot # 30021432, 30057743 REF Product Code: 7140-16-2.5; Size: 16Fr, 2.5cm; Lot # 30052745 REF Product Code: 7140-18-2.3; Size: 18Fr, 2.3cm; Lot # 0002968773 REF Product Code: 7140-18-5.5; Size: 18Fr, 5.5cm; Lot # 30052898 REF Product Code: 7140-20-2.0; Size: 20Fr, 2.0cm; Lot # 30054211
Other Recalls from Avanos Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1521-2025 | Class I | Brand Name: Ballard Product Name: Closed Sucti... | Mar 19, 2025 |
| Z-1523-2025 | Class I | Brand Name: Ballard Product Name: Closed Sucti... | Mar 19, 2025 |
| Z-1525-2025 | Class I | Brand Name: Ballard Product Name: Closed Sucti... | Mar 19, 2025 |
| Z-1528-2025 | Class I | Brand Name: Ballard Product Name: Closed Sucti... | Mar 19, 2025 |
| Z-1527-2025 | Class I | Brand Name: Ballard Product Name: Closed Sucti... | Mar 19, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.