Z-1542-06
Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus...
Micrus Endovascular Corporation / initiated 2006-09-08 / Terminated
Micrus Endovascular Corporation began a recall of Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA on . The reason FDA records is "During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1542-06
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Micrus Endovascular Corporation
- Product
- Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA
- Product code
- DQX Wire, Guide, Catheter
- Reason for recall
- During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream.
- FDA root cause
- Other
- Action
- On 9/8/06 the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
- Quantity in commerce
- 413 units
- Distribution
- Worldwide
- Product codes and lots
- All lots including F22741, F22742, F22743, F22744, F22745, F22746, F22747, F22749.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
