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Terminated

Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.

FDA Recall Z-0577-03 · Posted 2003-02-26

Recalling FirmCook Biotech, Inc.
Recall StatusTerminated
Product CodeDXY
Date Initiated2002-12-13
Date Terminated2003-05-27
Product Quantity153

Reason for Recall

Adverse events- suspected pseudoaneurysm

Firm Action

The remaining stocks were picked up at the hospital consignees on December 13 and 17, 2002.

Root Cause

Other

Distribution Pattern

Indiana

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001785SURGISIS PERIPHERAL VASCULAR PATCHCook Biotech, Inc. · 2000-12-27

Official Source

View FDA Recall →

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

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