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U.S. Department of Health and Human Services

Class 2 Device Recall Breast Pack Surgical Instrument Tray

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  Class 2 Device Recall Breast Pack Surgical Instrument Tray see related information
Date Initiated by Firm November 15, 2016
Create Date December 22, 2016
Recall Status1 Terminated 3 on June 21, 2018
Recall Number Z-0895-2017
Recall Event ID 75746
Product Classification Tray, biopsy, without biopsy instruments - Product Code FCH
Product BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Code Information Lot Number 1230323, Exp. Date December 2016;  Lot Number 1230387, Exp. Date December 2016;  Lot Number 1231616, Exp. Date December 2016
Recalling Firm/
Manufacturer		 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
75 Arkay Dr
Hauppauge NY 11788-3707
For Additional Information Contact Muhamad Ansari
631-435-4711 Ext. 254
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
Action Busse Hospital Disposables sent a Medical Device Correction letter (dated November 11, 2016) and response form to the three customers via FedEx on 11/15/2016 to inform them of the recall of the kits containing the affected gloves. This was done without notifying NYK-DO.
Quantity in Commerce US: 35 cases
Distribution PA, FL, VA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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