Class 2 Device Recall SafetyDeluxe Lumbar Puncture Tray

• Date Initiated by Firm: June 27, 2017
• Create Date: February 07, 2018
• Recall Status: Terminated on July 27, 2020
• Recall Number: Z-0540-2018
• Recall Event ID: 78950
• 510(K)Number: K032432 K110883
• Product Classification: Lumbar puncture tray (adult & pediatric) - Product Code PWY
• Product: Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
• Code Information: Lot Number/Expiration Date: 1) 1610300/Expiration Date 03/01/2019; 2) 1610503/Expiration Date 05/30/2019; 3) 1710059/Expiration Date: 09/30/2019; 4) 1610383/Expiration Date: 02/28/2019; 5) 1610463/Expiration Date: 05/30/2019; 6) 1610215/Expiration Date: 02/01/2019; 7) 1610114/Expiration Date: 11/01/2018; 8) 1610044/Expiration Date: 06/01/2018
• 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: 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: 470 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; 510(K)s with Product Code = PWY