LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device
FDA device recall Z-0070-2012 · posted 2011-10-19 · Terminated
Recall details
- Recalling firm
- Lemaitre Vascular, Inc.
- Reason for recall
- Extended Expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05
- Action taken
- 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 contact the Quality Assurance Engineer at 781-221-2266 ext. 183.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- MJN
- Quantity affected
- 144 units
- Distribution
- Nationwide distribution: USA including states of: CA, FL, IA, IL, MA, MI, NE, NJ, NY, OH, SC, TX, and WI.
- Date initiated
- 2011-10-04
- Date posted
- 2011-10-19
- Date terminated
- 2012-03-14
- Location
- Burlington, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) (K051067) | LeMaitre Vascular, Inc. | 2005-05-27 |