The Recall Desk
HighFDA (Devices)·Z-2969-2020·Announced 2020-09-23

Avanos MIC-KEY SF Gastrostomy Feeding Tube Recalled for Cracks

Avanos Medical is recalling 284 units of MIC-KEY SF Gastrostomy Feeding Tubes because the devices had cracked or detached from the feeding tube body.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect (cracking/detachment) presents a risk of harm to patients using the feeding tube, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Avanos Medical, Inc. is recalling 284 units of AVANOS MIC-KEY SF Gastrostomy Feeding Tubes. The recall was initiated because the devices had cracked or detached from the feeding tube body.

The affected products are distributed across several US states, including Oklahoma, Illinois, Wisconsin, Pennsylvania, Texas, New Jersey, and Louisiana, as well as Belgium. The recall covers multiple product codes and lot numbers, including sizes ranging from 12Fr to 20Fr.

Consumers who have these specific devices should stop using them and contact Avanos Medical for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Affected units
284

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)

  • 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
  • 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
  • 1.2cm
  • Lot # 30020941
  • 30046143 REF Product Code: 7120-14-1.5
  • 1.5cm

Distribution

Distributed in 7 states: