MIC-KEY Gastric-Jejunal Feeding Tube Kits Recalled for Incomplete Safety Information
Avanos Medical is recalling MIC-KEY Gastric-Jejunal Feeding Tube Kits because the Instructions for Use were missing required risk information about potential complications. No illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for missing safety information in product instructions. No illnesses or injuries reported, and the hazard is a documentation gap rather than a product defect or confirmed safety issue.
Plain-English summary
Avanos Medical, Inc. is recalling MIC-KEY Gastric-Jejunal Feeding Tube Kits. The Instructions for Use (IFU) were missing risk information about potential complications that a regulatory authority requested be included.
The recall affects feeding tube kits in multiple sizes and configurations, including both Non-ENFit and ENFit connector versions. All lot numbers of the affected product codes are included in the recall. Approximately 53,384 units have been distributed worldwide, including throughout the United States, Canada, Australia, and to government and military facilities.
No illnesses or injuries have been reported in relation to this recall.
The recalled product
- Product
- MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, ste
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- incomplete-labeling
- missing-risk-information
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 (20)
- All lot numbers. UDI-DI numbers: 1. 0270-14: 00350770472171
- 00350770472188
- 00350770472195
- 00350770472201
- 00350770472225
- 00350770472232
- 00350770472249
- 00350770472256
- 00350770472263
- 00350770472270
- 00350770472287
- 00350770472294
- 00350770472300
- 00350770472317
- 00350770472331
- 00350770472348
- 00350770472355
- 00350770472362
- 00350770472379
- 00350770472386
Distribution
Distributed nationwide across the United States.
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