FDA Medical Device Recalls (openFDA)
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables: SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
- Recall number
- Z-0896-2017
- Recalling firm
- Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
- Product
- SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
- Status
- Terminated
- Initiated
- 2016-11-15
- Posted
- not on file
- Terminated
- 2018-06-21
- 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: 82 cases
- Distribution
- PA, FL, VA
- Lot, serial or model codes
- Lot Number 1530330, Exp. Date November 2017; Lot Number 1530241, Exp. Date September 2017; Lot Number 1530095, Exp. Date September 2017; Lot Number 1431734, Exp. Date August 2017; Lot Number 1431066, Exp. Date May 2017
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSM
- Firm FEI
- 2433012
- Firm city
- Hauppauge
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28