NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.
This recall has been terminated (originally issued December 9, 2004).
- Company
- Boston Scientific Corp
- Recall Initiated
- October 21, 2004
- Posted
- December 9, 2004
- Terminated
- October 13, 2005
- Recall Number
- Z-0303-05
- Quantity
- 24 kits
- Firm Location
- Tech Park Glens Falls, NY
- Official Source
- View on FDA website ↗
Reason for Recall
The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.
Distribution
2 customers in IL and NV.
Lot / Code Info
988046
Root Cause
Other
Action Taken
Two customers contacted via phone on 10/21/04 and 10/22/04, followed by letters dated 11/17/2004. Customers instructed to discontinue use and return product. Distributor instructed to notify customers.
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