Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA- (Spiroflex Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).
This recall has been terminated (originally issued June 21, 2007).
- Company
- Possis Medical, Inc
- Recall Initiated
- May 1, 2007
- Posted
- June 21, 2007
- Terminated
- July 15, 2007
- Recall Number
- Z-0954-2007
- Quantity
- 69
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.
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.
Lot / Code Info
Model #: 105835-001 Lot # 73082
Root Cause
Other
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.
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