Recall Z-2770-2011 ยท DQO Catheter, Intravascular, Diagnostic
Vascular Solutions, Inc.
Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Langston dual lumen catheters are indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular,
| Date | Jul 11, 2011 (initiated Jun 9, 2011) |
| Status | Terminated |
| Reason | Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264. Recently it was reported that pouches containing Langston catheters (Model 5515) were missing a seal, posing a risk of product contamination. It is possible that a compromised sterile barrier |
| Root cause | Packaging process control |
| Action | Vascular Solutions, Inc. sent an "URGENT MEDICAL DEVICE FIELD ACTION- LOT SPECIFIC" letter dated June 7, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructed customers to check their inventory for the affected product and provided information on how to examine the product. Customers are to complete and return a Field Action Customer Inventory Form via fax at 763-656-4250 or e-mail at www.vascularsolutions.com. VSI Customer Service will contact customers to set up return shipment of affected product. A |
| Quantity | 23 (5 pack) boxes |
| Distribution | Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, MA, MI, MO, NM, NC, OK, and WA and the countries of Austria and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061565 | LANGSTON DUAL LUMEN CATHETER Vascular Solutions, Inc., Aug 2, 2006 |