Z-0797-2013Class II

Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case

Name: Z-0797-2013 Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case
Creator: Custom Healthcare Systems, Inc.
Published: 2012-11-26
License: https://open.fda.gov/license/

Manus Medical, LLC / initiated 2012-11-26 / Terminated / root cause: manufacturing process

FDA source

Custom Healthcare Systems, Inc. began a recall of 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... on 2012-11-26. FDA classified it as Class II and gives the reason as "Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0797-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-26
Posted: 2013-02-07
Terminated: 2013-02-08
Recalling firm: Manus Medical, LLC
Product: 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.
Product code: FCH Tray, Biopsy, Without Biopsy Instruments
Reason for recall: Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Custom Healthcare Systems, Inc. sent an Urgent Recall Letter dated November 19, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, quarantine affected product and return affected product to Stericycle using the label provided with the letter. Customer were also requested to complete and return the enclosed recall response form. For questions contact Hospira Customer Care at 1-877-946-7747.
Quantity in commerce: 80 trays
Distribution: USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
Product codes and lots: LOT NO. 60812 EXPIRES: 11 /2012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0797-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0796-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-07
Z-0797-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-07

Product code FCH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)