Z-1183-2007

Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension...

Name: Z-1183-2007 Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension...
Creator: Arizant Healthcare, Inc
Published: 2007-06-26
License: https://open.fda.gov/license/

Arizant Healthcare, Inc. / initiated 2007-06-26 / Terminated / root cause: packaging

FDA source

Arizant Healthcare, Inc began a recall of Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24200. For use with a Ranger... on 2007-06-26. The reason FDA records is "Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1183-2007
Status: Terminated
Initiated: 2007-06-26
Posted: 2007-08-18
Terminated: 2008-03-02
Recalling firm: Arizant Healthcare, Inc.
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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Lots B4798 through B4803 and Lot E5111

Product code FPA

K973741Class IIBair Hugger Blood/fluid WarmerAugustine Medical, Inc. / cleared 1998-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)