| Class 2 Device Recall Drainer(R) Centesis Catheters | |
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
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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
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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 |
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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.
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