Recall Z-0797-2013— Custom Healthcare Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Custom Healthcare Systems, Inc., initiated 2012-11-26, terminated 2013-02-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter..
- Recalling firm
- Custom Healthcare Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-26
- Terminated
- 2013-02-08
- Firm location
- Richmond, VA, United States
Product description
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.
Reason for recall
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Data sourced from openFDA. This site is unofficial and independent of the FDA.