Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Eve
FDA device recall Z-0954-2007 · 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
- MCX
- Quantity affected
- 69
- 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.