Recall Z-0351-2018
Hologic, Inc. · initiated July 7, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Codes / lots: UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165
Reason for recall
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.
FDA-determined cause: Component change control
Action taken
Letter
Details
- Recall number
- Z-0351-2018
- Initiated
- July 7, 2017
- Terminated
- April 4, 2018
- Product code
- OIJ – Biopsy Needle Guide Kit
- Quantity
- 12 (U.S.)
- Distribution
- US and OUS
- Recalling firm
- Hologic, Inc., Danbury, CT