Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550
FDA Recall Z-0104-2008 · Posted 2007-10-27
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Recalling FirmBoston Scientific
Recall StatusTerminated
Product CodeDQY
Date Initiated2007-09-11
Date Terminated2008-02-24
Product Quantity7
Reason for Recall
Missing holes: Catheters are missing the catheter's side holes.
Firm Action
A voice mail was left to affected members of the domestic sales force on September 11, 2007 and an interoffice memo with the recall implementation instructions was also sent to the Sales Force. An Urgent Voluntary Medical Device Recall letter dated September 11, 2007, was sent to affected consignees describing the problem and products affected. The letter included the customer steps for recall, a Reply Verification Tracking Form and a return shipping label.
Root Cause
Process control
Distribution Pattern
Worldwide: NY, PA, and Japan
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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