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.
What this means for you
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.
- Hazard
- deficient-manufacturing
- lidocaine-quality
Distribution
Distributed nationwide across the United States.
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