Recall Z-0895-2017 ยท FCH Tray, Biopsy, Without Biopsy Instruments
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
| Date | Nov 15, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | Busse Hospital Disposables sent a Medical Device Correction letter (dated November 11, 2016) and response form to the three customers via FedEx on 11/15/2016 to inform them of the recall of the kits containing the affected gloves. This was done without notifying NYK-DO. |
| Quantity | US: 35 cases |
| Distribution | PA, FL, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.