Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Natick, MA; REF/catalog no 840-733.
This recall has been terminated (originally issued November 11, 2009).
- Company
- Boston Scientific Corp
- Recall Initiated
- September 17, 2009
- Posted
- November 11, 2009
- Terminated
- October 8, 2010
- Recall Number
- Z-0175-2010
- Quantity
- 173
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170."
Distribution
Nationwide.
Lot / Code Info
Lots 12723202, 12745667, 12767883, 12777930, 12782625, 12808559, 12813607, 12850772 and 12861508.
Root Cause
Other
Action Taken
Consignees were notified by letter titled "Urgent Medical Device Recall-Immediate Action Required" dated 9/17/09 and instructed to cease using the product and to call the firm's customer service for return authorization. For additional information, call the firm at 866-868-4004.
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