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U.S. Department of Health and Human Services

Class 2 Device Recall CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

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  Class 2 Device Recall CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit see related information
Date Initiated by Firm March 16, 2020
Create Date April 29, 2020
Recall Status1 Terminated 3 on August 31, 2023
Recall Number Z-1822-2020
Recall Event ID 85260
510(K)Number K882867  
Product Classification Percutaneous endoscopic gastrostomy kit - Product Code PSG
Product CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Code Information 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 
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Thomas Kozma
470-448-5681
Manufacturer 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 Determined
Cause 2		 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 Avanos3862@stericycle.com 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PSG and Original Applicant = CORPAK CO.
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