Affirm Lateral Arm Upright Biopsy Accessory. Product recall
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Why was Affirm Lateral Arm Upright Biopsy Accessory. Product 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165
- Product
- Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
- Recalling firm
- Hologic, Inc.
- Quantity
- 12 (U.S.)
- Distribution
- US and OUS
- Recall date
- January 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)