AVID Medical Recalls Haylard Continuous Nerve Block Kits
AVID Medical is recalling 80 Haylard Continuous Nerve Block Kits due to potential sterility issues in included Sodium Chloride ampules.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class I. Per the rubric, an FDA Class I recall must be scored as at least 4 (Severe), as it indicates a reasonable probability of serious adverse health consequences.
Plain-English summary
AVID Medical, Inc. is recalling 80 units of the Haylard Continuous Nerve Block Tray, Model/Item Number BMCN001-05. The recall is due to potential product quality and sterility issues regarding the kits, specifically concerning the Sodium Chloride ampules included in the trays.
The affected kits are associated with Kit Lots 1703122, 1707656, and 1708053, and contain Sodium Chloride Ampules from Lot AB5002, which are subject to a separate recall by Spectra Medical. The recalled products were distributed domestically to Illinois, North Carolina, Virginia, and Wyoming.
Healthcare facilities and consumers should stop using these specific kits and contact AVID Medical for further instructions or a return. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Nerve Block Kit
- Affected units
- 80
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 (6)
- Model/Item Number (Kit): BMCN001-05
- UDI-DI: 10809160455128
- Kit Lots: 1703122
- 1707656
- 1708053
- Recalled Sodium Chloride Ampule Lot: AB5002
Distribution
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