''NAMIC Custom Angiographic Kit'' sold under the following labels: (1) Medical University of South Carolina. Pouch Catalog # 60131481; (2) Covenant Medical Center, Pouch Catalog #60131603; (3) St. Joseph Hospital, Pouch Catalog #60101041; (4) Spectrum Health, Pouch Catalog #61020031 (5) Rush Foundation Hospital, Kit #65185472 ****** Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** Each kit is customized to the needs of the particular hospital identified on the product labeling.
- Company
- Boston Scientific Corp
- Recall Initiated
- May 5, 2004
- Posted
- August 24, 2005
- Terminated
- August 31, 2005
- Recall Number
- Z-1393-05
- Quantity
- 1115 kits
- Firm Location
- Tech Park Glens Falls, NY
Reason for Recall
Molded handles used in Angiographic Manifolds may be occluded.
Distribution
The kits were custom made and sold to consignees in IL, KY, MI, SC, and TX.
Lot / Code Info
(1) Medical University of SC label: Lot 942414 (2) Covenant label: Lot 939982, 943645; (3) St. Joseph label: Lot 940424; (4) Spectrum label: Lot 940054 (5) Rush Foundation label: Lot 945456; 943043
Root Cause
Other
Action Taken
Letters dated 5/4/2004 to Risk Managers with instructions to return product.
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