FDA recall Z-0546-2018
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables · Class II · device
Product
Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 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-0546-2018