Z-1666-2011

Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged...

Name: Z-1666-2011 Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged...
Creator: Maquet Cardiovascular, LLC
Published: 2011-02-23
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2011-02-23 / Terminated / root cause: labeling and UDI

FDA source

Maquet Cardiovascular, LLC began a recall of 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... on 2011-02-23. The reason FDA records is "Tubing connectors incorrectly packaged and labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1666-2011
Status: Terminated
Initiated: 2011-02-23
Posted: 2011-03-16
Terminated: 2012-09-13
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.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: Tubing connectors incorrectly packaged and labeled.
Root cause tag: labeling and UDI
FDA 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: [email protected]. If you have any additional questions, please contact your local MAQUET Cardiovascular Sales Representative or customer service at 1-800-777-4222.
Quantity in commerce: 40 BEQ-HG 0284 3/8" x 3/8" Lot 70041098 Connectors
Distribution: Nationwide distribution: USA state of CA.
Product codes and lots: 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)

Product code DWE

K080592Class IIHlm Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG / cleared 2008-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)