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Recall Observatory FDA recall evidence

Device product

CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.

Z-0894-2017

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: 14 cases
Official record key
device-enforcement:Z-0894-2017

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 1230783, Exp. Date February 2017; Lot Number 1330825, Exp. Date April 2018

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.