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U.S. Department of Health and Human Services

Class 1 Device Recall Medical Action Industries, dialysis kit

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  Class 1 Device Recall Medical Action Industries, dialysis kit see related information
Date Initiated by Firm November 06, 2009
Date Posted March 30, 2010
Recall Status1 Terminated 3 on June 01, 2011
Recall Number Z-1075-2010
Recall Event ID 53880
510(K)Number K013621  
Product Classification dialysis kit - Product Code FPA
Product Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
Code Information Part number: 57977, Lot numbers: 62394, 63042 and 64820.
Recalling Firm/
Manufacturer		 Medical Action Industries Inc
25 Heywood Rd
Arden NC 28704-9302
For Additional Information Contact Robert M. Dugan
828-681-8820 Ext. 266
Manufacturer Reason
for Recall		 Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI.
Quantity in Commerce 2,520 kits
Distribution Nationwide distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FPA and Original Applicant = BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
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