Soft Tissue Biopsy Trays recalled due to deficient manufacturing practices
Bard Access Systems is recalling soft tissue biopsy trays (models 4380 Economy and 4382A) due to lidocaine ampoules being manufactured under deficient manufacturing practices.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source identifies a deficient manufacturing practice in lidocaine ampoules but does not report any illnesses, injuries, or hospitalizations, making it a precautionary recall without evidence of actual harm.
Plain-English summary
Bard Access Systems, Inc. is recalling two models of soft tissue biopsy trays: the Model 4380 Economy Soft Tissue Biopsy Tray (UDI-DI: 0110885403108563) and the Model 4382A Soft Tissue Biopsy Tray (UDI-DI: 0110885403108501). These devices are intended for use in the collection of aspirate tissue such as liver and kidney samples.
The recall is due to lidocaine ampoules included with these trays being manufactured under deficient manufacturing practices by the ampoule manufacturer. Approximately 11,990 units have been distributed worldwide and throughout the United States, including all fifty states, Washington D.C., Puerto Rico, and Belgium.
Affected lot numbers include: 4380 model lot REKY3390; 4382A model lots REKY3393, REJZ0942, and REJZ0943. Healthcare providers and facilities who have received these biopsy trays should stop using them and contact Bard Access Systems for instructions on return or replacement.
The recalled product
- Product
- 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 11,990
Distribution
Part of a larger recall action
This product is one of 14 recalled by Bard Access Systems, 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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