AVID Medical Recalls Halyard Line Insertion Packs Due to Metal Flakes
AVID Medical is recalling Halyard Line Insertion Packs because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product where injury has not yet been reported, specifically the potential for foreign body reactions from metal flakes entering a surgical site.
Plain-English summary
AVID Medical, Inc. is recalling Halyard LINE INSERTION PACK - Medical convenience kits, Model Number MAMC217-18. The recall involves 30 units distributed nationwide in the United States. The affected products have GTIN 10809160345658 and Lot Numbers 1594486 and 1594624.
The recall is being conducted because sponge forceps and towel clamps associated with the kits may have small loose metal flakes that could detach. These metal flakes may enter a patient's surgical site undetected, potentially causing local reactions or possible foreign body reactions.
Healthcare facilities and consumers should stop using the affected products and contact AVID Medical, Inc. for further instructions or a return.
The recalled product
- Product
- Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 30
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 (2)
- GTIN: 10809160345658 Lot Number: 1594486
- 1594624
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 73 recalled by AVID 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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