The Recall Desk
HighFDA (Devices)·Z-1822-2020·Announced 2020-05-06

Avanos Medical Recalls CORFLO PEG Kits Due to Potential Adapter Occlusion

Avanos Medical is recalling CORFLO Percutaneous Endoscopic Gastrostomy (PEG) Kits because the tube may become blocked at the adapter, potentially delaying or aborting procedures.

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 hazard involves a risk-of-harm product (medical device) where the defect could lead to procedure delays or aborts, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Avanos Medical, Inc. is recalling 1,766 units of CORFLO Percutaneous Endoscopic Gastrostomy (PEG) Kits. The recall affects specific product codes and lot numbers, including the CORFLO PEG Kit, CORFLO PEG Kit with ENFit Connector, and CORFLO Safety PEG Kit with ENFit Connector.

The recall was initiated because the CORFLO PEG tube may become blocked at the center of the adapter (occluded). This defect potentially causes a procedure to be delayed or aborted. The affected products were distributed worldwide and nationwide in the United States, with specific distribution to states including AZ, CA, CT, FL, GA, IA, ID, IL, LA, MO, MN, MD, NY, NM, NV, NJ, OR, OK, OH, RI, TN, TX, WA, and WI. Foreign distribution included Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Romania, United Arab Emirates, and United Kingdom.

Healthcare providers and consumers should stop using the affected CORFLO PEG Kits and contact Avanos Medical for further instructions or replacement.

The recalled product

Product
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Gastrostomy Tubes
Hazard
Affected units
1,766

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 (19)

  • CORFLO* PEG Kit: Product Code: 30-6012 with lot# 0203214820
  • 0203251844 Product Code: 30-6016 with lot# 0002997221
  • 0020006332 Product Code: 30-6020 with lot# 0002994174
  • 0020008547
  • 0203245678 Product Code: 50-6012E1 with lot#: 0203251785
  • 0020003356 Product Code: 50-6012E2 with lot#: 0002997217
  • 0203239802
  • 2001368 Product Code: 50-6016E1 with lot#: 0002994170
  • 0203241062
  • 0203214905
  • 0203245676
  • 0203251843
  • 0020003029
  • 0203261078 Product Code: 50-6016E2 with lot#: 0203261079
  • 20012261
  • 0203239803
  • 0002994171
  • 0203239804
  • 0203248168

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Related recalls

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Same hazard · device occlusion

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