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.
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 3/5 (High).
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.
- 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
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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