FDA Device recall Z-0541-2018
Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure by Robert Busse And D B A Busse Hospital Disposables, citing BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0541-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-27 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Robert Busse And D B A Busse Hospital Disposables |
| Distribution | US |
Product
Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure
Reason
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Identifiers
| code_info | Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018; 2) 1610277/Expiration Date: 03/01/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0541-2018%22
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