—#103349

Product

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 product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K883880
Affected lot / code info: UPN Code: M001461930. Catalog: 46-193. Batch/Lot Description: 14270326.

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

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.

Timeline

Recall initiated: 2011-08-01
Posted by FDA: 2011-08-23
Terminated: 2012-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103349. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.