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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium Firm PVC Thoracic Catheter 36FR Straight

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  Class 2 Device Recall Atrium Firm PVC Thoracic Catheter 36FR Straight see related information
Date Initiated by Firm September 29, 2023
Date Posted December 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-0484-2024
Recall Event ID 93408
510(K)Number K831931  
Product Classification Catheter, cholangiography - Product Code GBZ
Product Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Code Information UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24.
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information Contact
603-880-1433
Manufacturer Reason
for Recall		 A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Medical Device - Removal notice was sent via Fed-Ex on October 25, 2023. The letter advises customers to check for and remove from inventory Atrium Firm PVC Catheter 36 FR Straight, part number 15036, lot ME234686. Forward this information to all current and potential Atrium Firm PVC Thoracic Catheter 36FR Straight users within your hospital / facility, or to any customer product was further distributed to. Contact your local Atrium/Getinge Customer Service department at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)to request a return authorization (RMA) and shipping instructions to return any affected product.
Quantity in Commerce 2460 units (246 cases, 10 units/case)
Distribution US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & 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.
510(K) Database 510(K)s with Product Code = GBZ and Original Applicant = ATRIUM MEDICAL CORP.
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