Z-0541-2018Class II

Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977

Name: Z-0541-2018 Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977
Creator: Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Published: 2017-06-27
License: https://open.fda.gov/license/

Busse Hospital Disposables / initiated 2017-06-27 / Terminated / root cause: manufacturing process

FDA source

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables began a recall of Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure on 2017-06-27. FDA classified it as Class II and gives the reason as "BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0541-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-27
Posted: 2018-02-07
Terminated: 2020-07-27
Recalling firm: Busse Hospital Disposables
Product: Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure
Product code: PWY Lumbar Puncture Tray (Adult & Pediatric)
Reason for recall: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On June 27, 2017, Busse Hospital Disposables distributed Urgent Medical Device Recall notices and Response Forms to their customers via courier service. A copy of the supplier's recall notice was also provided to customers. Customers were advised to conduct the following: " Discontinue use of needle immediately. " Please check your inventory and cease distribution immediately. " If you have distributed the above products, please contact your customers and inform them of this recall immediately. " Contact Busse Hospital Disposables for a Return Good Authorization number. " Complete and Return the Response Form via fax to 631-435-2849 or via email to: [email protected]. Customers with questions may call 631-435-4711, ext. 254.
Quantity in commerce: 28 cases
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018; 2) 1610277/Expiration Date: 03/01/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0541-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0540-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06
Z-0541-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06
Z-0542-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06
Z-0543-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06
Z-0544-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06
Z-0545-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06
Z-0546-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06

Product code PWY

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)