Recall Z-2269-2012— Baxter Healthcare Corp.

Name: FDA recall Z-2269-2012
Creator: U.S. Food and Drug Administration
Published: 2011-03-04

Class III · Terminated

Class III FDA medical device recall by Baxter Healthcare Corp., initiated 2011-03-04, terminated 2012-08-27. It names one FDA 510(k) clearance: K930459. Product: Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.. Reason: 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.

Recalling firm: Baxter Healthcare Corp.
Classification: Class III
Status: Terminated
Initiated: 2011-03-04
Terminated: 2012-08-27
Firm location: Round Lake, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K930459 — BARD MINI-INFUSER 1500 & 3000Bard Medsystems Div.·cleared 1993-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.