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Recall Observatory FDA recall evidence

Device product

Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure

Z-0540-2018

June 27, 2017

Class II

Product summary

Firm
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Event
Event 78950
Status
Terminated
Classification
Class II
Quantity
470 cases
Official record key
device-enforcement:Z-0540-2018

Official wording

Reason: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

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;

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign matter