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U.S. Department of Health and Human Services

Class 2 Device Recall Drainer(R) Centesis Catheters

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  Class 2 Device Recall Drainer(R) Centesis Catheters see related information
Date Initiated by Firm May 04, 2018
Create Date June 18, 2018
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-2249-2018
Recall Event ID 80135
Product Classification Accessories, catheter - Product Code KGZ
Product Drainer(R) Centesis Catheters:
(a) REF 8810, 5F x 9cm
(b) REF 8811, 6F x 9cm
(c) REF 8812, 5F x 15cm

Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.
Code Information a) REF 8810, 5F x 9cm, Lot Numbers: 18037128, 18057123 (b) REF 8811, 6F x 9cm, Lot Numbers: 18026062, 18026063 (c) REF 8812, 5F x 15cm, Lot Number: 18050076
Recalling Firm/
Manufacturer		 Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove MN 55369-6032
For Additional Information Contact
763-656-4300
Manufacturer Reason
for Recall		 The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
FDA Determined
Cause 2		 Other
Action Galt Medical Corp. sent an Urgent Medical Device Recall dated May 2, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. The firm requested the following actions be taken: Those with affected stock, were directed to immediately discontinue use and quarantine any product. If the affected product was further distributed, the distributor was directed to immediately contact all parties who may have received the affected stock and recover any unused product. For questions contact your local sales representative or Recall Coordinator at 214-778-1306 or email quality@galtneedletech.com
Quantity in Commerce 276 units
Distribution US Nationwide Distribution
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.
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