Z-0895-2017Class II

BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables...

Name: Z-0895-2017 BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables...
Creator: Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Published: 2016-11-15
License: https://open.fda.gov/license/

Busse Hospital Disposables / initiated 2016-11-15 / Terminated / root cause: labeling and UDI

FDA source

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables began a recall of BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298 on 2016-11-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0895-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-15
Posted: 2016-12-22
Terminated: 2018-06-21
Recalling firm: Busse Hospital Disposables
Product: BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Product code: FCH Tray, Biopsy, Without Biopsy Instruments
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: US: 35 cases
Distribution: PA, FL, VA
Product codes and lots: Lot Number 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0895-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0894-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0895-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0896-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

Product code FCH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)