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Recall Observatory FDA recall evidence

Device 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.

Z-0796-2013

November 26, 2012

Class II

Product summary

Firm
Custom Healthcare Systems, Inc.
Event
Event 64084
Status
Terminated
Classification
Class II
Quantity
80 trays
Official record key
device-enforcement:Z-0796-2013

Official wording

Reason: Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.

Code information: LOT NO. 100212 EXPIRES: 06/2013

Distribution pattern: USA Nationwide Distribution including the states GA, OH, GA, NC and ME.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter