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.
This recall has been terminated (originally issued August 18, 2007).
- Company
- Arizant Healthcare, Inc
- Recall Initiated
- June 26, 2007
- Posted
- August 18, 2007
- Terminated
- March 2, 2008
- Recall Number
- Z-1183-2007
- Quantity
- 85,710
- Firm Location
- Eden Prairie, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.
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.
Lot / Code Info
Lots B4798 through B4803 and Lot E5111
Root Cause
Other
Action Taken
All consignees will be contacted by Urgent Medical Device Recall letter on 6/26/07.