Recall Z-2249-2018
Vascular Solutions, Inc. · initiated May 4, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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: Other
Action taken
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
Details
- Recall number
- Z-2249-2018
- Initiated
- May 4, 2018
- Terminated
- October 5, 2020
- Product code
- KGZ – Accessories, Catheter
- Quantity
- 276 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Vascular Solutions, Inc., Maple Grove, MN