MIC Gastric-Jejunal Feeding Tube Kits Recalled Over Defective Syringe
Avanos Medical is recalling MIC Gastric-Jejunal Feeding Tube Kits because they contain a sterile pre-filled syringe that was subsequently recalled by Nurse Assist. Approximately 10,808 units have been distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recalls indicate serious potential hazards to health and safety. Although no reported illnesses or injuries are documented in the source, the agency's classification as Class I justifies a Severe rating.
Plain-English summary
MIC Gastric-Jejunal Feeding Tube Kits with ENFit Connectors are being recalled by Avanos Medical. The kits contain multiple product variants in sizes of 16 Fr, 18 Fr, and 22 Fr, designed for either endoscopic/radiologic or surgical placement. Approximately 10,808 units have been affected by this recall.
The recall was initiated because the kits contain a sterile pre-filled syringe that was subsequently recalled by Nurse Assist. The FDA has classified this as a Class I recall, indicating a serious potential hazard.
The affected products have been distributed nationwide throughout the United States as well as internationally to Canada, Colombia, Costa Rica, the United Arab Emirates, Israel, Kuwait, and Panama.
Patients and healthcare providers should discontinue use of the affected MIC Gastric-Jejunal Feeding Tube Kits and contact Avanos Medical for further instructions regarding replacement or proper handling of existing inventory. The specific product codes and batch numbers affected are documented in the FDA recall notice.
The recalled product
- Product
- MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Pla
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- Affected units
- 10,808
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)
- a) Product Code 8250-16
- UDI/DI 350770445410
- Batch Numbers: 30180762
- 30226671
- 30226823
- 30233440
- 30238985
- 30242039
- 30254749
- 30265005
- 30266483
- 30265374
- 30268260
- 30270862
- b) Product Code 8250-16-15
- UDI/DI 350770445427
- Batch Numbers: 30226822
- 30242228
- 30253956
- c) Product Code 8250-16-22
Distribution
Part of a larger recall action
This product is one of 2 recalled by Avanos Medical, 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.
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