Class 2 Device Recall Breast Pack Surgical Instrument Tray

• Date Initiated by Firm: November 15, 2016
• Create Date: December 22, 2016
• Recall Status: Terminated 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: 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.