CORFLO Safety PEG kit 50-4320 contains recalled lidocaine injection
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 49 kits affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where an injectable drug with unresolved quality issues was packed into sterile kits, a risk of harm with no injuries reported.
Plain-English summary
The CORFLO Safety PEG Kit with ENFit Connector, model/catalog number 50-4320, is being recalled. The action covers 49 kits.
The stated reason is that lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, was included in sterile kits and sets. The FDA classified the action as Class II.
Affected product is UDI-DI 10350770007578, lot numbers 30365230, 30367013 and 30373825. Distribution was nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number, UDI-DI and lot numbers above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
- Manufacturer
- Avanos Medical, Inc.
- Category
- Medical Device — Gastrostomy kit
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI 10350770007578
- Lot Numbers 30365230
- 30367013
- 30373825
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Avanos Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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