Boston Scientific Mach 1 peripheral Guide Catheter 7F, MP Multipurpose, .081 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-723, UPN M001197230, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311
FDA Recall Z-1304-2008 · Posted 2008-05-07
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2008-02-07
Date Terminated2008-11-03
Product Quantity10
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.