—#105682

Product

HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr.

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: 1967243 1967244 1973126 1979964 1979965 1979966 1981255 1981256 1981257 1981258 1981259 1995557 2007279 2007280 2007281 2007282 2019645 2019646 2025136 2025137 2025138 2025140 2025143 2025144 2025145 2042619 2042620 2042621 2042622 2042623 2042624 2042625 2049440 2049441 2049442 2059476 2059477 2059478 2059479 2064019 2064020 2064021 2068143 2068144 2068145 2068146 2077341 2077342 2083509 2087640 2090784 2090785 2090786 2095293 2095294 2099545 2099546 2105392

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 #105682. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.