CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
Breast Pack, Surgical Instrument Tray recalled
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling Breast Pack, Surgical Instrument Tray, distributed in Florida, Pennsylvania, Virginia. The recall was initiated on 15 Nov 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0895-2017
- FDA event ID
- 75746
- Recalling firm
- Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, Hauppauge, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Nov 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 15 Nov 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +37 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Where it was distributed
PA, FL, VA
Questions about this recall
Is Breast Pack, Surgical Instrument Tray recalled?
Yes. Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables recalled Breast Pack, Surgical Instrument Tray on 15 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0895-2017.
Why was it recalled?
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.
Which lots are affected?
Lot Number 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016
Where was it sold?
PA, FL, VA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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