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U.S. Department of Health and Human Services

Class 2 Device Recall Meridian Hemodialysis Instrument

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 Class 2 Device Recall Meridian Hemodialysis Instrumentsee related information
Date Initiated by FirmDecember 02, 2004
Date PostedDecember 08, 2004
Recall Status1 Terminated 3 on July 21, 2006
Recall NumberZ-0299-05
Recall Event ID 30499
510(K)NumberK992894 
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
ProductBaxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
Code Information serial numbers 200101 to 202190
Recalling Firm/
Manufacturer		 Baxter Healthcare Renal Div
1620 Waukegan Rd Bldg R
Mc Gaw Park IL 60085-6730
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.
FDA Determined
Cause 2		Other
ActionBaxter sent Urgent Device Correction letters dated 12/2/04 to all Meridian customers on the same date. The letters informed the accounts of the potential for disconnection of the power cord and teh potential for arcing, fire or electrical shock. The accounts were requested to examine their instruments to see if a new power cord clamp has been installed on the unit, using the enclosed instructions and complete the enclosed reply sheet indicating the number of units already corrected, and the number of units still requiring the power cord clamp. The accounts were requested to fax the completed reply for to Baxter at 847-270-5457.
Quantity in Commerce3,004 units
DistributionNationwide and internationally to Mexico, China and Korea.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KDI
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