AVID Medical Recalls Haylard 18G Single Shot Epi Trays Due to Sterility Concerns
AVID Medical is recalling 1,640 Haylard 18G Single Shot Epi Trays because they contain Sodium Chloride ampules subject to a separate recall for potential quality and sterility issues.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which the rubric defines as a situation where use or exposure to a product may cause serious adverse health consequences or death. The rubric mandates a score of at least 4 for FDA Class I recalls.
Plain-English summary
AVID Medical, Inc. is recalling 1,640 units of the Haylard 18G Single Shot Epi Tray, Model/Item Number DPGE002-02. The recall is being conducted because the kits contain Sodium Chloride ampules that are subject to a separate recall by Spectra Medical. The specific hazard identified is the potential for product quality and sterility issues regarding these ampules.
The affected kits are identified by the following lot numbers: 1641713, 1641714, 1659697, and 1668209. The recalled Sodium Chloride ampules are from Lot AB4003. The UDI-DI for the product is 10809160410325.
The recalled products were distributed domestically in Illinois, North Carolina, Virginia, and Wyoming. The source text does not specify the exact end-users or facilities where these kits were distributed. Users should stop using the affected kits and contact AVID Medical, Inc. for further instructions or a return.
The recalled product
- Product
- Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 1,640
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 (7)
- Model/Item Number (Kit): DPGE002-02
- UDI-DI: 10809160410325
- Kit Lots: 1641713
- 1641714
- 1659697
- 1668209
- Recalled Sodium Chloride Ampule Lot: AB4003
Distribution
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