FDA recall Z-0543-2018

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables · Class II · device

Product

Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure

Reason for recall

BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2017-06-27
Report date
2018-02-14
Termination date
2020-07-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0543-2018