RecallDepth

NAMIC Custom Angiographic Kit, Left Heart Kit - . Model #H749651947220. Catalog # 65194722. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.

Company
Boston Scientific Corp
Recall Initiated
October 21, 2004
Posted
December 9, 2004
Terminated
October 13, 2005
Recall Number
Z-0302-05
Quantity
128 kits
Firm Location
Tech Park Glens Falls, NY

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.

Distribution

2 customers in IL and NV.

Lot / Code Info

Lot #990024

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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