Z-1822-2020Class II

CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

Name: Z-1822-2020 CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Creator: Avanos Medical, Inc.
Published: 2020-03-16
License: https://open.fda.gov/license/

Halyard Health / initiated 2020-03-16 / Terminated

FDA source

Avanos Medical, Inc. began a recall of CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit on 2020-03-16. FDA classified it as Class II and gives the reason as "The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1822-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-16
Posted: 2020-04-29
Terminated: 2023-08-31
Recalling firm: Halyard Health
Product: CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Product code: PSG Percutaneous Endoscopic Gastrostomy Kit
Reason for recall: The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
FDA root cause: Under Investigation by firm
Action: On March 16, 2020 Avanos Medical (formerly Halyard Health) sent out an URGENT Product Recall Notice via letter identifying the problem and under what circumstances it can occur. PRODUCTS: This Recall applies to the previously mentioned CORFLO* PEG Kits that were manufactured after April 8, 2019 and can be identified by the product code and lot number found on the CORFLO* PEG Kit label. ACTION TO BE TAKEN BY CUSTOMER: CHECK all storage and usage locations to determine if any impacted product remains within your possession for any Unsold Inventory SEGREGATE and QUARANTINE the devices according to your facility 's procedures, then IMMEDIATELY COMPLETE and RETURN the attached Recall Acknowledgement Form to Avanos. If consignee is located In the USA send form by email to Avanos3862@stericycle .com or by FAX to 1-866-324-3738 If consignee is Outside the USA, please send by email to Avanos38620US@stericycle .com or by FAX to +44 0800 069 8520. The consignee should CONTACT Stericycle at 1-888-899-9298 to request the documentation packet needed to return the product. Once the documentation packet is received the customer should follow the instructions on how to return to the product to Avanos (via Stericycle) using the pre-paid label and packing slip provided. Avanos will credit the distributor and send notification to credit the end user. Sold Inventory- If you received any of the impacted products but they are no longer in your inventory IMMEDIATELY COMPLETE the attached Recall Acknowledgement Form checking the box indicating that you have no inventory, then RETURN the form to Avanos. If In the USA send it by email to [email protected] or by FAX to 1-866-324-3738 If outside the USA, customer should send response by email to Avanos38620US@stericycle .com or by FAX to +44 0800 069 8520.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1822-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1822-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29

Product code PSG

K882867Class IICorpak Percutaneous Endoscopic Gastrostomy TubeCorpak Co. / cleared 1988-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)