Recall Z-0070-2012 ยท MJN Catheter, Intravascular Occluding, Temporary
Lemaitre Vascular, Inc.
LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal carotid arteri
| Date | Oct 19, 2011 (initiated Oct 4, 2011) |
| Status | Terminated |
| Reason | Extended Expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05 |
| Root cause | Incorrect or no expiration date |
| Action | The firm, LeMaitre Vascular, Inc., sent an "URGENT: 9F PRUITT F3 Carotid Shunt Device Field Safety Notice" dated October 4, 2011 to its customers. The notice describes the product, problem and action to be taken. The customers were instructed to identify their inventory; return the affected products for exchange with a properly labeled device; contact Le Matire customer service for replacement at 800-628-9470, and complete and return the RECALL NOTICE RECONCILIATION FORM via fax to 781-425-5049, even if no product is on hand. If you have any questions concerning this safety notice, please |
| Quantity | 144 units |
| Distribution | Nationwide distribution: USA including states of: CA, FL, IA, IL, MA, MI, NE, NJ, NY, OH, SC, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051067 | PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) LeMaitre Vascular, Inc., May 27, 2005 |