Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311
- Recall Initiated
- February 7, 2008
- Posted
- May 7, 2008
- Terminated
- November 3, 2008
- Recall Number
- Z-1305-2008
- Quantity
- 4
- Firm Location
- Scientific Place Natick, MA
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: 20039169
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.
More recalls by Boston Scientific Corporation One Boston
EndoVive Safety PEG Kits 24 F
Universal Product Number (UPN): MOO56648 1
The product provides nutri...
Sep 17, 2008
EndoVive Safety PEG Kits 20 F
Universal Product Number (UPN): MOO566460
The product provides nutrit...
Sep 17, 2008
Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm
Made in Ireland...
Aug 26, 2008