Z-2340-2026Class II
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description...
Halyard Health / initiated 2026-04-30 / Open, Classified / root cause: manufacturing process
Avanos Medical, Inc. began a recall of Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No on . FDA classified it as Class II and gives the reason as "Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2340-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Halyard Health
- Product
- Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
- Product code
- KNT Tubes, Gastrointestinal (And Accessories)
- Reason for recall
- Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Root cause tag
- manufacturing process
- FDA 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 potentially affected devices have been transferred. 3. Complete and return the Customer Response Form as instructed, including identifying whether you have inventory of the affected product available for return. Distributors: 1. Provide customers a copy of this notification. Instruct customers to follow the actions outlined in this letter. 2. Provide refunds or credits to your customers in accordance with your internal processes. 3. Submit an updated Customer Response Form to Avanos to account for product distributed to your customers and to receive applicable replacement product.
- Quantity in commerce
- 54 kits
- Distribution
- US Nationwide distribution.
- Product codes and lots
- UDI-DI 10350770007530, Lot Numbers 30365233, 30367015, 30372821, 30378386
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2333-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2334-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2335-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2336-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2337-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2338-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2339-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2340-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2341-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2342-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2343-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2344-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2345-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2346-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2347-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2348-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2349-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2350-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2351-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2352-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.