Recall Z-1300-2008 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
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
| Date | May 7, 2008 (initiated Feb 7, 2008) |
| Status | Terminated |
| Reason | Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length. |
| Root cause | Labeling mix-ups |
| 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. |
| Quantity | 35 |
| Distribution | 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. |
| FDA record | Open on fda.gov |