FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
- Recall number
- Z-1373-2016
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Product
- Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
- Status
- Terminated
- Initiated
- 2016-02-23
- Posted
- not on file
- Terminated
- 2019-09-25
- Reason
- Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
- Root cause
- Unknown/Undetermined by firm
- Action
- 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.
- Quantity
- 72,000 units in total
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- BEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32 USA, RF-32, RF-32 USA, RF-32u.
- 510(k) numbers
- ["K080470"]
- PMA numbers
- not on file
- Product code
- KFM
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28