Recall Z-0895-2017— Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Class II · Terminated
Class II FDA medical device recall by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, initiated 2016-11-15, terminated 2018-06-21. FDA's recall record names no specific 510(k) clearance for this event. Product: BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.. Reason: 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..
- Recalling firm
- Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-15
- Terminated
- 2018-06-21
- Firm location
- Hauppauge, NY, United States
Product description
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.