CLASS II Device recall · Reported 13 Feb 2013 · FDA Enforcement Report
Custom Breast Biopsy Tray w/Sodium Chloride recalled
Custom Healthcare Systems is recalling Custom Breast Biopsy Tray w/Sodium Chloride, distributed nationwide in the US. The recall was initiated on 26 Nov 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0797-2013
- FDA event ID
- 64084
- Recalling firm
- Custom Healthcare Systems, Richmond, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Nov 2012
- FDA classified
- 7 Feb 2013
- Reported
- 13 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 26 Nov 2012 | Recall initiated by company | |
| 7 Feb 2013 | Classified by FDA | +73 days |
| 13 Feb 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Product as listed by the FDA
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, 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.
Where it was distributed
USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
Questions about this recall
Is Custom Breast Biopsy Tray w/Sodium Chloride recalled?
Yes. Custom Healthcare Systems recalled Custom Breast Biopsy Tray w/Sodium Chloride on 26 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-0797-2013.
Why was it recalled?
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Which lots are affected?
LOT NO. 60812 EXPIRES: 11 /2012
Where was it sold?
USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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