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Terminated

HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; HEK25/100CPUT; HEK12/75CPUT; HEK10/150CPUT.

FDA Recall Z-0638-04 · Posted 2004-07-20

Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeDSY
Date Initiated2003-12-30
Date Terminated2006-01-19
Product Quantity710 units

Reason for Recall

Water permeability of the patch is out of specification.

Firm Action

Recall letters were sent to the customers via US Mail return receipt on 12/30/2003.

Root Cause

Other

Distribution Pattern

The product has been shipped nationwide to 53 hospitals, 4 government hospitals, and 3 sales representatives.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983819INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THINIntervascular, Inc. · 1998-11-24

Official Source

View FDA Recall →

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

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