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Terminated

''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.

FDA Recall Z-1393-05 · Posted 2005-08-24

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeDTZ
Date Initiated2004-05-05
Date Terminated2005-08-31
Product Quantity1115 kits

Reason for Recall

Molded handles used in Angiographic Manifolds may be occluded.

Firm Action

Letters dated 5/4/2004 to Risk Managers with instructions to return product.

Root Cause

Other

Distribution Pattern

The kits were custom made and sold to consignees in IL, KY, MI, SC, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K782095STOPCOCKS, MANIFOLDSNamic · 1979-01-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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