Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SET UP PACK Surgical Instrument Tray

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall SET UP 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-0896-2017
Recall Event ID 75746
Product Classification Tray, surgical, instrument - Product Code FSM
Product SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
Code Information 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
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: 82 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.
-
-