Boston Scientific Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, 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. Order No. REF: 46-193 (M001461930). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, 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. Order No. REF: 46-193 (M001461930).
Brand
Boston Scientific
Lot Codes / Batch Numbers
Lot/Batch #: 9052739
Products Sold
Lot/Batch #: 9052739
Boston Scientific is recalling Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i. due to Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indica. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly.
Recommended Action
Per FDA guidance
An Urgent Medical Device Recall letter, dated December 12, 2006 was sent to affected hospitals Risk Manager beginning 12/12/2006. The letter describes the issue and product affected, requests that further distribution or use of any remaining product cease immediately, and provides information for returning product to Boston Scientific Replacement product will be issued for all recalled product returned from affected facilities. A Reply Verification Tracking Form is requested to be completed and returned to Boston Scientific by Wednesday, December 27, 2006.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, IN, NY
Page updated: Jan 10, 2026