Recall Z-0540-2018 ยท PWY Lumbar Puncture Tray (Adult & Pediatric)
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
| Date | Jun 27, 2017 |
| Status | Terminated |
| Reason | BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification. |
| 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 Re |
| Quantity | 470 cases |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |