—#105686

Product

Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1 Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min - 530 ml/min.

FDA product code: LGZ — Warmer, Thermal, Infusion Fluid
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K911383
Affected lot / code info: Lot Numbers: 1974580 2007256 2064012 2089416 2093985

Why it was recalled

Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets

Root cause (FDA determination)

Device Design

Action the firm took

Smiths Medical notified consignees by letter dated November 28, 2011 titled: Urgent Field Safety Notice. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to inspect inventory and segregate unused affected product. Distributors were instructed to immediately stop distributing and quarantine all inventory. The letters included a Confirmation Form to be complete and return, by fax to 781-610-9859 or by email to hotlineconnectorrecall@smiths-medical.com. For questions consignees were instructed to contact Smiths Medical at 1781-763-9330.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 160 Weymouth St, Rockland, Massachusetts 02370-1136

Distribution

Distribution pattern: Worldwide Distribution (USA) (nationwide) - Argentina, Austria, Australia, Belgium, Bahrain, Bermuda, Canada, Chile, China, Columbia, Czech Republic, Germany, Denmark, Estonia, Egypt, Finland, France, Great Britain, Guernsey, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel India, Iceland, Italy, Japan, South Korea, Kazakhstan, Lebanon, Luxembourg, Mexico, Malaysia, New Caledonia, Netherlands, Norway, New Zealand, Panama, Poland, Portugal, Qatar, Singapore, Sweden, Slovak Republic, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, and Vatican City State.

Timeline

Recall initiated: 2011-11-21
Posted by FDA: 2012-01-11
Terminated: 2014-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105686. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.