Custom Breast Biopsy Tray recall: Particulate Matter
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Why was Custom Breast Biopsy Tray recalled?
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
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?
LOT NO. 100212 EXPIRES: 06/2013
- Product
- Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
- Recalling firm
- Custom Healthcare Systems, Inc.
- Quantity
- 80 trays
- Distribution
- USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
- Recall date
- February 13, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)