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
|
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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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