Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene Oxide, Possis Medical, Inc., 9
FDA device recall Z-1131-2007 · posted 2007-08-10 · Terminated
Recall details
- Recalling firm
- Possis Medical, Inc
- Reason for recall
- Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary vessels. These units should indicated use only for peripheral arteries.
- Action taken
- A Urgent Medical Device recall letter dated 19 June 2007, was sent to consignees advising that all unused product be removed and returned to Possis. An acknowledgement of the disposiiton of the product will be requested from consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 194
- Distribution
- AR, AZ, CA, FL, GA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI, WV
- Date initiated
- 2007-06-19
- Date posted
- 2007-08-10
- Date terminated
- 2008-03-02
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER (K050794) | Possis Medical, Inc. | 2005-04-28 |