''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.
This recall has been terminated (originally issued August 24, 2005).
- 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
- Official Source
- View on FDA website ↗
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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