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Recall Observatory FDA recall evidence

Device product

Nerve Block Tray (Nerve Block convenience kit)

Z-0943-2015

October 23, 2014

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 70081
Status
Terminated
Classification
Class II
Quantity
480 kits
Official record key
device-enforcement:Z-0943-2015

Official wording

Reason: According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.

Code information: CMP Kit code: DT13405 Lot numbers: 2014061250 and 2014071750 Expiration date lot 2014061250: 2016-02 Expiration date lot 2014071750: 2016-03

Distribution pattern: Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate