Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, IN
FDA device recall Z-0955-2007 · posted 2007-06-21 · Terminated
Recall details
- Recalling firm
- Possis Medical, Inc
- Reason for recall
- Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.
- Action taken
- Consignees were notified of the problem on May 1, 2007 via a Urgent Medical Device Recall Letter. The consignees were instructed to quarantine the product until a Possis Representative contacts them. The representative will examine the units and determine which ones to be returned to Possis. They were also asked to fill and return the attached form.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 45
- Distribution
- Nationwide including states of AK, AR, AZ, CA, CT, FL,IL, IN, KY, MD, ME, MI, MN, MS, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, WA, and WI.
- Date initiated
- 2007-05-01
- Date posted
- 2007-06-21
- Date terminated
- 2007-07-15
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) (K042874) | Possis Medical, Inc. | 2004-11-05 |