FDAClass IIDecember 28, 2016

SET UP PACK Surgical Instrument Tray recall: Labeling Error

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

Why was SET UP PACK Surgical Instrument Tray recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing #…
Recalling firm
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Quantity
US: 82 cases
Distribution
PA, FL, VA
Recall date
December 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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