Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
- Company
- Boston Scientific Corporation
- Recall Initiated
- October 9, 2008
- Posted
- January 28, 2009
- Terminated
- July 27, 2009
- Recall Number
- Z-0837-2009
- Quantity
- 1033 units
- Firm Location
- Fremont, CA
Reason for Recall
Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.
Distribution
Worldwide Distribution --- USA including Puerto Rico and country of Panama
Lot / Code Info
Batch/lot #s 11420600, 11420601, 11420602, 11611665, 11716746, 11720663, 11721240, 11722752, 11727107, 11727873, 11727874, 11728458, 11731354, 11732665, 11735762, 11736559, 11739563, 11742590, 11754455, 11758051, 11764281, 11777994, 11788045, 11790848, 11820112, 11897802, 11897904, and 11904295
Root Cause
Labeling mix-ups
Action Taken
Recall initiated on October 6, 2008, and notification letters sent on October 8, 2008. Letters were sent via FedEx. Responses are being tracked along with delivery verification. For additional information contact Boston Scientific Corporation at 1-508-652-5594.
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