Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Steril
FDA device recall Z-0103-2008 · posted 2007-10-27 · Terminated
Recall details
- Recalling firm
- Boston Scientific
- Reason for recall
- Missing holes: Catheters are missing the catheter's side holes.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 6
- Distribution
- Worldwide: NY, PA, and Japan
- Date initiated
- 2007-09-11
- Date posted
- 2007-10-27
- Date terminated
- 2008-02-24
- Location
- Maple Grove, MN
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