NAMIC Custom Angiographic Kit, Left Heart Kit - . Model #H749651947220. Catalog # 65194722. Firm on kit label: Manufactu
FDA device recall Z-0302-05 · posted 2004-12-09 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- The kits contain defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 128 kits
- Distribution
- 2 customers in IL and NV.
- Date initiated
- 2004-10-21
- Date posted
- 2004-12-09
- Date terminated
- 2005-10-13
- Location
- Glens Falls, NY
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