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U.S. Department of Health and Human Services

Class 3 Device Recall InfusO.R.

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 Class 3 Recall
InfusO.R.
see related information
Date Posted February 18, 2011
Recall Status1 Terminated on August 27, 2012
Recall Number Z-1378-2011
Recall Event ID 57666
Premarket Notification
510(K) Number
K883577 
Product Classification Pump, Infusion - Product Code FRN
Product InfusO.R. Infusion Pump, an Rx syringe infusion pump; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product codes 2L3100, 2L3100R, 2L3100U, 6461500 and 6461500R. These product codes includes refurbished units and InfusO.R. pumps previously sold under the Bard label. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician.
Code Information All serial numbers.
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer 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 InfusOR will not operate. The reason being that the InfusOR (2L3100) 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
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Safety Alert letters dated January 11, 2011 were mailed via first class mail to the InfusOR direct accounts, to the attention of the Director of Biomedical Engineering, the Director of Anesthesia and the Director of Materials Management, on the same date, informing them that over-the-counter Energizer C size alkaline batteries should not be used with the InfusO.R. Pumps (Product codes 2L3100, 2L3100R, 2L3100R, 2L3100U, 2L3100N, 6461500 and 6461500R). That particular battery incorporates a feature that may inhibit electrical contact and affect the ability of the pump to power-up. The accounts were requested to check their inventory of InfusO.R. Pumps for the presence of over-the-counter Energizer C size alkaline batteries. The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST. *** Baxter expanded the scope of their action to include the Mini-Infuser System and sent Urgent Device Correction letters dated 3/4/11 via First Class mail to all InfusOR and Mini-Infuser customers who had purchased either of the affected product lines. The letters informed the accounts that the Mini-Infusers use the same size battery and incorporate the same battery contact interface as the InfusOR pump, and that the same feature that inhibits electrical contact in over-the counter Energizer C size batteries may also be incorporated by other battery manufacturers. The accounts were requested to verify that the InfusOR and Mini-Infuser will power-on before use; if the device does not power on, replace the batteries with a different brand of size C batteries and verify that the device will power-on before use; and to place a copy of the letter with each operator's manual for the InfusOR and Mini-Infuser System for future refer.
Quantity in Commerce 39,725 pumps
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = C.R. BARD, INC.
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