CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report
Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle recalled
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, distributed nationwide in the US. The recall was initiated on 27 Jun 2017 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-0541-2018
- FDA event ID
- 78950
- Recalling firm
- Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, Hauppauge, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2017
- FDA classified
- 6 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 27 Jun 2017 | Recall initiated by company | |
| 6 Feb 2018 | Classified by FDA | +224 days |
| 14 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle recalled?
Yes. Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables recalled Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle on 27 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0541-2018.
Why was it recalled?
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Which lots are affected?
Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018; 2) 1610277/Expiration Date: 03/01/2019
Where was it sold?
US Nationwide Distribution
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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