| Class 2 Device Recall Arizant Healthcare Ranger Blood/Fluid Warming Set | |
Date Initiated by Firm | June 26, 2007 |
Date Posted | August 18, 2007 |
Recall Status1 |
Terminated 3 on March 02, 2008 |
Recall Number | Z-1184-2007 |
Recall Event ID |
38409 |
510(K)Number | K973741 |
Product Classification |
Blood/Fluid Warming Set - Product Code FPA
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Product | Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24250. 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
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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 | 12,000 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = FPA
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