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U.S. Department of Health and Human Services

Class 2 Device Recall Busse JOINT INJECTION TRAY

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  Class 2 Device Recall Busse JOINT INJECTION TRAY see related information
Date Initiated by Firm October 21, 2022
Date Posted November 29, 2022
Recall Status1 Open3, Classified
Recall Number Z-0325-2023
Recall Event ID 91079
Product Classification Nerve block tray - Product Code OGJ
Product Busse JOINT INJECTION TRAY -Intended as a nerve block
REF No. 8561 R1
Code Information UDI-DI: (01)00849233016712 Lot Number: 2230276
Recalling Firm/
Manufacturer		 Busse Hospital Disposables, Inc.
75 Arkay Dr
Hauppauge NY 11788-3707
Manufacturer Reason
for Recall		 Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
FDA Determined
Cause 2		 Device Design
Action Busse issued Product Recall Notification Letter dated 10/20/22 to Distributor; End User via Email on 10/21/2022 and Certified Mail on 10/24/2022 Letter states reason for recall, health risk and action to take: 1. Immediately check your inventory for the lots listed above. 2. Do not use the drape included in the product with the lot number(s) listed above. 3. Complete the enclosed Response Form within the next 10 days and return via email to csabillon@busseinc.com even if you have no affected product on hand. a. If you do have product in stock, destroy the drape following your facility policy.
Quantity in Commerce 80 cases
Distribution TX
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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