Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
FDA Recall Z-0540-2018 · Posted None
Recall StatusTerminated
Product CodePWY
Date Initiated2017-06-27
Date Terminated2020-07-27
Product Quantity470 cases
Reason for Recall
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.