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U.S. Department of Health and Human Services

Class 2 Device Recall Arizant Healthcare Ranger Blood/Fluid Warming Set

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  Class 2 Device Recall Arizant Healthcare Ranger Blood/Fluid Warming Set see related information
Date Initiated by Firm June 26, 2007
Date Posted August 18, 2007
Recall Status1 Terminated 3 on March 02, 2008
Recall Number Z-1183-2007
Recall Event ID 38409
510(K)Number K973741  
Product Classification Blood/Fluid Warming Set - Product Code FPA
Product Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24200. For use with a Ranger warming unit.
Code Information Lots B4798 through B4803 and Lot E5111
Recalling Firm/
Manufacturer		 Arizant Healthcare, Inc
10393 W 70th St
Eden Prairie MN 55344-3446
For Additional Information Contact
952-947-1200
Manufacturer Reason
for Recall		 Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.
FDA Determined
Cause 2		 Other
Action All consignees will be contacted by Urgent Medical Device Recall letter on 6/26/07.
Quantity in Commerce 85,710
Distribution Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL., IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of United Kingdom, France, Switzerland, Germany, India, Canada, Australia, Netherlands, Italy, Sweeden, South Korea, and Greece.
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 = AUGUSTINE MEDICAL, INC.
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