MIC Safety 24 Fr push OTW PEG kits contain recalled lidocaine
MIC Safety PEG Kits with ENFit Connectors, 24 Fr PUSH OTW, catalog number 8170-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
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 MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors, 24 Fr PUSH OTW, model/catalog number 8170-24, is being recalled. The action covers 234 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 10350770007837, lot numbers 30371847, 30374834, 30378748 and 30380347. 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: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
- Manufacturer
- Avanos Medical, Inc.
- Category
- Medical Device — Gastrostomy kit
- Affected units
- 234
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 (5)
- UDI-DI 10350770007837
- Lot Numbers 30371847
- 30374834
- 30378748
- 30380347
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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