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Recall Observatory FDA recall evidence

Device product

SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147

Z-0896-2017

November 15, 2016

Class II

Product summary

Firm
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Event
Event 75746
Status
Terminated
Classification
Class II
Quantity
US: 82 cases
Official record key
device-enforcement:Z-0896-2017

Official wording

Reason: Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

Code information: Lot Number 1530330, Exp. Date November 2017; Lot Number 1530241, Exp. Date September 2017; Lot Number 1530095, Exp. Date September 2017; Lot Number 1431734, Exp. Date August 2017; Lot Number 1431066, Exp. Date May 2017

Distribution pattern: PA, FL, VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.