Recall Z-1822-2020 ยท PSG Percutaneous Endoscopic Gastrostomy Kit
Avanos Medical, Inc.
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
| Date | Mar 16, 2020 |
| Status | Terminated |
| Reason | The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted. |
| 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 t |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE Corpak Co., Sep 21, 1988 |