FDA Device recall Z-0895-2017
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listin…
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listin… by Robert Busse And D B A Busse Hospital Disposables, citing 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 reca….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0895-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-15 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Robert Busse And D B A Busse Hospital Disposables |
| Distribution | FL, PA, VA |
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.
Identifiers
| code_info | Lot Number 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Robert Busse And D B A Busse Hospital Disposables
- Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical p…
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables
All Robert Busse And D B A Busse Hospital Disposables recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0895-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.