FDA-Device2016-12-28Class II
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Hazard
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Sold states
PA, FL, VA
Affected count
US: 35 cases
Manufactured in
75 Arkay Dr, N/A, Hauppauge, NY, United States
Products
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0895-2017Don't want to check this manually?
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