Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550
This recall has been terminated (originally issued October 27, 2007).
- Company
- Boston Scientific
- Recall Initiated
- September 11, 2007
- Posted
- October 27, 2007
- Terminated
- February 24, 2008
- Recall Number
- Z-0104-2008
- Quantity
- 7
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Missing holes: Catheters are missing the catheter's side holes.
Distribution
Worldwide: NY, PA, and Japan
Lot / Code Info
Lot/Batch # 559022
Root Cause
Process control
Action Taken
A voice mail was left to affected members of the domestic sales force on September 11, 2007 and an interoffice memo with the recall implementation instructions was also sent to the Sales Force. An Urgent Voluntary Medical Device Recall letter dated September 11, 2007, was sent to affected consignees describing the problem and products affected. The letter included the customer steps for recall, a Reply Verification Tracking Form and a return shipping label.
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