—#98121

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.

FDA product code: DWE — Tubing, Pump, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K080592
Affected lot / code info: 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)

Why it was recalled

Tubing connectors incorrectly packaged and labeled.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: Nationwide distribution: USA state of CA.

Timeline

Recall initiated: 2011-02-23
Posted by FDA: 2011-03-16
Terminated: 2012-09-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98121. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.