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.
FDA Recall Z-1184-2007 · Posted 2007-08-18
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Recalling FirmArizant Healthcare, Inc
Recall StatusTerminated
Product CodeFPA
Date Initiated2007-06-26
Date Terminated2008-03-02
Product Quantity12,000
Reason for Recall
Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.
Firm Action
All consignees will be contacted by Urgent Medical Device Recall letter on 6/26/07.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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