Recall Z-1184-2007 ยท FPA Set, Administration, Intravascular
Arizant Healthcare, Inc
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.
| Date | Aug 18, 2007 (initiated Jun 26, 2007) |
| Status | Terminated |
| Reason | Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed. |
| Root cause | Other |
| Action | All consignees will be contacted by Urgent Medical Device Recall letter on 6/26/07. |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973741 | BAIR HUGGER BLOOD/FLUID WARMER Augustine Medical, Inc., Apr 30, 1998 |