Reported Sep 5, 2012 · Terminated
Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These…
Baxter Healthcare Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · Rt. 120 & Wilson Rd · Round Lake, IL · 60073
Is this the product you have?
- Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump
- Product UsageThese product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician
- UsageThe Mini-Infuser System is designed for controlled intermittent administration of intravenous medication
- Lot codes and dates
- product codes 2M8170 and 2M8170R, all serial numbers
- Amount recalled
- 26,485 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches ¿.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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