Katzen" Infusion Wire, 0.035 in x 180 cm, UPN Product No. M001461930, RED Catalog No. 46-193, Made in USA 8600. Boston Scientific. NW 41 Street, Miami, FL 33166. Intended for the infusion of therapeutic agents (i.e., heparin, saline, thrombolytic agents, etc) in the peripheral vasculature. The wire allows for the delivery of agents in either a "pulse -spray" or " slow weep" technique.
FDA Recall Z-3053-2011 · Posted 2011-08-23
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQX
Date Initiated2011-08-01
Date Terminated2012-08-10
Product Quantity33
Reason for Recall
Boston Scientific is voluntarily recalling one lot/batch of Katzen" Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The labels indicate a device length of 180cm while the actual device length is 145cm.
Firm Action
Boston Scientific sent an "Urgent Medical Device Recall Removal" letter dated August 1, 2011 to all affected customers.
The letter described the problem and product being recalled and advised customers to segregate the affected product immediately and return it to Boston Scientific. Boston Scientific requested the completion and return of the Reply Verification Tracking Form.
For additional information on this recall call Boston Scientific Quality Systems at (763) 494-1133.
Root Cause
Labeling mix-ups
Distribution Pattern
(USA) Nationwide distribution including the states of AZ, AR, CA, CO, FL, GA, IL, IN, NV, NY, NC, OH, PA, RI, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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