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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium 36Fr Right Angled Firm PVC Thoracic Catheter

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  Class 2 Device Recall Atrium 36Fr Right Angled Firm PVC Thoracic Catheter see related information
Date Initiated by Firm June 19, 2015
Date Posted August 05, 2015
Recall Status1 Terminated 3 on March 21, 2016
Recall Number Z-2346-2015
Recall Event ID 71510
510(K)Number K831931  
Product Classification Catheter, cholangiography - Product Code GBZ
Product Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10)
Part Number: 15236
Code Information Lot Number : ME215673 EXp: 2019/09
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
5 Wentworth Dr
Hudson NH 03051-4929
For Additional Information Contact
603-880-1433
Manufacturer Reason
for Recall		 Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
FDA Determined
Cause 2		 Employee error
Action Atrium Medical notified accounts by letter dated 6/18/15, explaining the mislabeled inner units. If any product is discovered with incorrect labeling, the product may be used or product may be returned for credit. contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
Quantity in Commerce 62 cases (10/cs)=620 units
Distribution AZ, CA, LA. IN, NC, TN, TX, 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.
510(K) Database 510(K)s with Product Code = GBZ and Original Applicant = ATRIUM MEDICAL CORP.
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