Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part
FDA device recall Z-1184-2007 · posted 2007-08-18 · Terminated
Recall details
- Recalling firm
- Arizant Healthcare, Inc
- Reason for recall
- Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.
- Action taken
- All consignees will be contacted by Urgent Medical Device Recall letter on 6/26/07.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 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,
- Date initiated
- 2007-06-26
- Date posted
- 2007-08-18
- Date terminated
- 2008-03-02
- Location
- Eden Prairie, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAIR HUGGER BLOOD/FLUID WARMER (K973741) | Augustine Medical, Inc. | 1998-04-30 |