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Terminated

Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft lenght, 90 cm, Catalon Number: 34356-446, UPN H749343564460, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

FDA Recall Z-1300-2008 · Posted 2008-05-07

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2008-02-07
Date Terminated2008-11-03
Product Quantity35

Reason for Recall

Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.

Firm Action

Consignees were sent a Boston Scientific Urgent Voluntary Medical Device Recall letter on 2/7/08. The letter included the customer steps for recall, a complete listing of all product batches being recalled, the Reply Verification Tracking Form(s) and a return shipping label.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution including USA states of PA, AZ, NY, KY, CA, WV, OH, WA, MI, TN, IN, IL, NJ, KY, FL, AR, FL, NC, CO, TX, WV, WI, OR, AL, MN and ND and countries of BE, FR, GB, DE, IE, IT, JP, AU, SOUTH KOREA, NZ, TR, TW and ZA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0200286F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXXBoston Scientific · 2002-01-22K0108746F MACH 1, MODEL 34356-XXXBoston Scientific Corp · 2001-06-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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