The Recall Desk
HighFDA (Devices)·Z-1260-2023·Announced 2023-03-22

Bard Mission Disposable Core Biopsy Instrument Kit Recall: Sizing Incompatibility

Bard Peripheral Vascular is recalling certain Bard Mission Disposable Core Biopsy Instrument Kits due to sizing incompatibility between the biopsy instrument and coaxial needle, which could cause procedural delays or needle breakage.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is classified as FDA Class II with no reported injuries or illnesses. The recall addresses a sizing incompatibility that presents a potential risk of needle breakage and procedural complications, but these are theoretical risks not documented to cause actual patient harm.

Plain-English summary

Bard Peripheral Vascular Inc. is recalling approximately 38,635 Bard Mission Disposable Core Biopsy Instrument Kits due to a sizing incompatibility between the biopsy instrument and the coaxial needle. The recalled kits include model 16G x 10CM (REF: 1610MSK) and model 18G x 16CM (REF: 1816MSK), distributed worldwide to the United States, Canada, Korea, Thailand, and Taiwan.

The incompatibility occurs because the external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle. This defect could lead to procedural delays, requiring an additional device to complete the procedure, or needle tip breakage if the incompatible components are used together.

Specific lot numbers and expiration dates are listed in the FDA recall notice. Healthcare providers who have received these kits should discontinue use and contact Bard Peripheral Vascular Inc. for replacement or return instructions.

The recalled product

Product
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Biopsy Instruments
Hazard
  • device-incompatibility
  • needle-breakage

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 (20)

  • REF/UDI-DI/Lot(Expiration Date): 1610MSK/00801741142567/1445630(11/28/2024)
  • 1449980(12/28/2024)
  • 1451134(1/28/2025)
  • 1816MSK/00801741097065/1447510(12/28/2024)
  • 1447511(12/28/2024)
  • 1447512(12/28/2024)
  • 1447513(12/28/2024)
  • 1448118(12/28/2024)
  • 1448119(12/28/2024)
  • 1448120(12/28/2024)
  • 1448121(12/28/2024)
  • 1448743(12/28/2024)
  • 1450413(12/28/2024)
  • 1450414(12/28/2024)
  • 1451075(1/28/2025)
  • 1451076(1/28/2025)
  • 1451621(1/28/2025)
  • 1451622(1/28/2025)
  • 1451625(1/28/2025)
  • 1451626(1/28/2025)

Distribution

Distributed nationwide across the United States.

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