Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-666, UPN M001196660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311
This recall has been terminated (originally issued May 7, 2008).
- Recall Initiated
- February 7, 2008
- Posted
- May 7, 2008
- Terminated
- November 3, 2008
- Recall Number
- Z-1303-2008
- Quantity
- 17
- Firm Location
- Scientific Place Natick, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
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.
Lot / Code Info
Lot Number: 20030656
Root Cause
Labeling mix-ups
Action Taken
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.