AVID Medical Recalls Haylard Basic Biopsy Trays Due to Sterility Concerns
AVID Medical is recalling Haylard Basic Biopsy Trays because they contain Sodium Chloride ampules subject to a separate recall for 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 indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls must be scored at least 4.
Plain-English summary
AVID Medical, Inc. is recalling 240 kits of the Haylard Basic Biopsy Tray, Model/Item Number PM415. The recall is due to potential product quality and sterility issues associated with the Sodium Chloride ampules included in the kits. These specific ampules are subject to a separate recall by Spectra Medical.
The affected kits were distributed domestically in Illinois, North Carolina, Virginia, and Wyoming. The recall includes specific kit lots (1652485, 1656642, 1667835, 1676219, 1682251, 1691940) and recalled Sodium Chloride Ampule Lots AB5002 and AB4003.
Healthcare facilities and consumers should stop using these specific kits and contact AVID Medical, Inc. for further instructions or a return.
The recalled product
- Product
- Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Biopsy Tray
- Hazard
- Affected units
- 240
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 (10)
- Model/Item Number (Kit): PM415
- UDI-DI: 10809160322154
- Kit Lots: 1652485
- 1656642
- 1667835
- 1676219
- 1682251
- 1691940
- Recalled Sodium Chloride Ampule Lot: AB5002
- AB4003
Distribution
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