Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc

FDA device recall Z-2770-2011 · posted 2011-07-11 · Terminated

Recall details

Recalling firm

Vascular Solutions, Inc.

Reason for recall

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

Action taken

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. All affected product will be replaced upon receipt of the shipped product. Customers should contact their local Sales Representative for questions concerning this recall.

Root cause

Packaging process control

Status

Terminated

Product code

DQO

Quantity affected

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.

Date initiated

2011-06-09

Date posted

2011-07-11

Date terminated

2012-04-05

Location

Maple Grove, MN

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