Recall Z-2335-2026 ยท KNT Tubes, Gastrointestinal (And Accessories)
Avanos Medical, Inc.
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
| Date | Jun 5, 2026 (initiated Apr 30, 2026) |
| Status | Open, Classified |
| Reason | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. |
| Root cause | Material/Component Contamination |
| Action | On May 1, 2026, Avanaos Medical, Inc. issued a "Urgent: Medical Device Recall" Notification to affected consignees via Email. Avanos asked consignees to take the following actions: 1. Immediately review your inventory and identify any affected product. 1a. Quarantine all affected lots to prevent further use or distribution. 1b. Discontinue use of the affected lidocaine hydrochloride injection 1%, 5 mL and return the entire unused kit to Avanos Medical, Inc. for destruction. 2. This notice needs to be passed on to all those who need to be aware within your organization or functions where the p |
| Quantity | 31 kits |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE Corpak Co., Sep 21, 1988 |