FDAClass IIMay 6, 2020

CORFLO Percutaneous Endoscopic Gastrostomy recall

CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

Why was CORFLO Percutaneous Endoscopic Gastrostomy recalled?

The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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, 0203251786 CORFLO* PEG Kit with ENFit¿ Connector Product Code: 50-4016E1 with lot#: 0020008354, 0020008547, 0020008666 Product Code: 50-4020E1 with lot#: 0020008544 Product Code: 50-6012 with lot#: 0203214902, 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, 20011367 Product Code: 50-6020 with lot#: 0203214903 Product Code: 50-6020E2 with lot#: 0203214901, 0203239804, 0203248168, 20011369 CORFLO* Safety PEG Kit with ENFit¿ Connector Product Code: 50-6316 with lot#: 0203241064 CORFLO* PEG Kit with ENFit¿ Connector Product Code: 50-6520 with lot#: 0203241063

Product
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Recalling firm
Avanos Medical, Inc.
Quantity
1766
Distribution
Worldwide and US Nationwide Distribution: AZ, CA, CT, FL, GA, IA, ID, IL, LA, MO, MN, MD, NY, NM, NV, NJ, OR, OK, OH, RI, TN, TX, WA, WI, ***Foreign: Distributed to Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Romania, United Arab Emirates, United Kingdom
Recall date
May 6, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls