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Terminated

Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, - 0.038" recom guidewire, 1000 psi pressure limit. Usage: 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, intravascular and interventricular pressure gradients.

FDA Recall Z-2608-2010 · Posted 2010-09-28

Recalling FirmVascular Solutions, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2010-09-02
Date Terminated2012-04-24
Product Quantity1,128 boxes ( 5pk)

Reason for Recall

Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723. Recently, it was reported that pouches containing Langston Pigtail catheter (Model 5540) were missing a seal, posing a risk of product contamination. It is possib

Firm Action

Consignees were sent on 9/2/10, a Vascular Solutions "Urgent Medical Device Field Action" letter dated September 1, 2010. The letter was addressed to Cath Lab Manager. The letter descried the product and the problem. Provided instructions to examine pouches of opened boxes to see if they have not been sealed. If unsealed, they recommended to remove pouches from the current inventory. For unopened boxes they recommended to remove the boxes from the inventory. Requested consignees to complete the Field Action Customer Inventory Form included with the letter. For any questions, please contact the firm at 763-656-6032.

Root Cause

Process control

Distribution Pattern

AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS,MO, NE, NY,NH, NJ, NM, NY,NC, OH, OK, OR, A, PR, SC, TN, TX, UT, VA, WA, WV, WI, and WY. SINGAPORE, MEXICO, CANADA, SPAIN, AUSTRIA, GERMANY, ITALY, ENGLAND, and SWITZERLAND.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051395LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETERVascular Solutions, Inc. · 2005-06-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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