The Recall Desk
HighFDA (Devices)·Z-0288-2016·Announced 2015-11-25

Civco Biopsy Starter Kit Recalled Due to Sterility Concerns

Civco Medical Instruments is recalling 1,139 boxes of Biopsy Starter Kits because the sterility of the product cannot be assured.

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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (infection) from a medical device where sterility cannot be assured, fitting the 'High' severity criteria for risk-of-harm products without reported injuries.

Plain-English summary

Civco Medical Instruments Co. Inc. is recalling 1,139 boxes of CIVCO Biopsy Starter Kits. These reusable, non-sterile brackets are used with Infiniti Plus needle guides for needle-guided or catheter procedures with diagnostic ultrasound transducers. The recall is being conducted because the sterility of the product cannot be assured.

The affected products were distributed nationwide in the United States and internationally to numerous countries, including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. The recall covers multiple reference numbers and lot codes associated with the Infiniti Plus needle guide systems.

Healthcare facilities and consumers who have these products should stop using them immediately. Civco Medical Instruments is the recalling firm responsible for the recall. No specific instructions for disposal or return are provided in the source text, but users should contact the manufacturer or their supplier for further guidance.

The recalled product

Product
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047,
Manufacturer
Civco Medical Instruments Co. Inc.
Category
Medical Device — Biopsy Equipment
Hazard
Affected units
1,139

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)

  • M475840
  • M475850
  • M483080
  • M184760
  • M201120
  • M201220
  • M201230
  • M229890
  • M230450
  • M248410
  • M265470
  • M282270
  • M307490
  • M322230
  • M367370
  • M370090
  • M381360
  • M421260
  • M431550
  • M452150

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Civco Medical Instruments Co. 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.

See all 5 products in this recall →

Related recalls

Same manufacturer · Civco Medical Instruments Co. Inc.

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Same hazard · infection risk

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