Reported Jan 24, 2018 · Terminated
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc. · 36 and 37 Apple Ridge Rd · Danbury, CT · 06810-7301
Is this the product you have?
- Affirm Lateral Arm Upright Biopsy Accessory
- Product NumberASY-09880
- Lot codes and dates
- UDI Number15420045506817
- Serial NumbersLAT1200100 LAT1200165
- Amount recalled
- 12 (U.S.)
Why it was recalled
The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.
This product could cause temporary or reversible health problems — stop using it.
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