Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

FDA Recall Z-1822-2020 · Posted None

Recalling FirmAvanos Medical, Inc.
Recall StatusTerminated
Product CodePSG
Date Initiated2020-03-16
Date Terminated2023-08-31
Product Quantity1766

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑