FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets.
- Recall number
- Z-1666-2011
- Recalling firm
- Maquet Cardiovascular, LLC
- Product
- Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets.
- Status
- Terminated
- Initiated
- 2011-02-23
- Posted
- 2011-03-16
- Terminated
- 2012-09-13
- Reason
- Tubing connectors incorrectly packaged and labeled.
- Root cause
- Other
- Action
- The firm, Maquet, sent a "PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION" letter dated February 22, 2011 via Federal Express to its customer. The letter described the product, problem and the action to be taken. The customer was instructed to examine their inventory immediately to identify and remove the affected connectors and complete and return the attached RECALL- Device Corrective Action Response Form via fax to Director of Regulatory Affairs at (973) 709-7016 or email: whitney.torning@maquet.com. If you have any additional questions, please contact your local MAQUET Cardiovascular Sales Representative or customer service at 1-800-777-4222.
- Quantity
- 40 BEQ-HG 0284 3/8" x 3/8" Lot 70041098 Connectors
- Distribution
- Nationwide distribution: USA state of CA.
- Lot, serial or model codes
- BEQ-HG 0284 Connector 3/8" x 3/8" Lot 70041098; BEQ-HG 1113 Connector 3/16" x 3/16" Lot 70041096 (note that this code was in the connector mispackaged in the box)
- 510(k) numbers
- ["K080592"]
- PMA numbers
- not on file
- Product code
- DWE
- Firm FEI
- 2242352
- 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