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U.S. Department of Health and Human Services

Class 2 Device Recall SafetyDeluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle

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  Class 2 Device Recall SafetyDeluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle see related information
Date Initiated by Firm June 27, 2017
Create Date February 07, 2018
Recall Status1 Terminated 3 on July 27, 2020
Recall Number Z-0541-2018
Recall Event ID 78950
510(K)Number K032432  K110883  
Product Classification Lumbar puncture tray (adult & pediatric) - Product Code PWY
Product Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977

Product Usage:
Surgical procedure
Code Information Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018; 2) 1610277/Expiration Date: 03/01/2019
Recalling Firm/
Manufacturer		 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
75 Arkay Dr
Hauppauge NY 11788-3707
Manufacturer Reason
for Recall		 BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
FDA Determined
Cause 2		 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: ijacobo@busseinc.com. Customers with questions may call 631-435-4711, ext. 254.
Quantity in Commerce 28 cases
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PWY and Original Applicant = BUSSE HOSPITAL DISPOSABLES
510(K)s with Product Code = PWY and Original Applicant = BUSSE HOSPITAL DISPOSABLES, INC.
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