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Recall Observatory FDA recall evidence

Device product

BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

Z-0895-2017

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: 35 cases
Official record key
device-enforcement:Z-0895-2017

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 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016

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.