Reported Feb 13, 2013 · Terminated
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product…
Custom Healthcare Systems, 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: Custom Healthcare Systems, Inc. · 4205 Eubank Rd · Richmond, VA · 23231-4328
Is this the product you have?
Custom Breast Biopsy Tray w/Sodium ChlorideCatalog # B9-15263Apackaged in bags1 tray/bag20 bags/case
- Product UsageA sterile medical device containing multiple components utilized by physician to perform a breast biopsy
- Lot codes and dates
- LOT NO. 60812
- EXPIRES11 /2012
- Amount recalled
- 80 trays
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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