HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
This recall has been terminated (originally issued February 23, 2016).
- Recall Initiated
- February 23, 2016
- Terminated
- September 25, 2019
- Recall Number
- Z-1372-2016
- Quantity
- 72,000 units in total
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Distribution
US Nationwide Distribution.
Lot / Code Info
HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786
Root Cause
Unknown/Undetermined by firm
Action Taken
The firm, Maquet Inc., sent an "URGENT MEDICAL DEVICE RECALL" Letter/Response Form dated 2/23/2016 via Fed Ex to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the list to determine if you have the affected products; monitor patients for signs; monitor and treat signs according to your protocols and clinical judgments; support shock symptoms and maintain circulatory and hemodynamics per your facility's protocol and care guidelines, and complete and and return the enclosed Response Form by email to: MCPrecall2016@maquet.com or fax to: 1-973-629-1518 within three (3) business days. For any questions, please contact your Maquet sales and representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2) Monday through Friday, between the hours of 8:00am and 6:00pm EST.