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Terminated

IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.

FDA Recall Z-1222-06 · Posted 2006-07-12

Recalling FirmInternational Biophysics Corp
Recall StatusTerminated
Product CodeDWE
Date Initiated2005-08-16
Date Terminated2006-07-17
Product Quantity179 units.

Reason for Recall

Tyvek pouches containing device labeled as sterile have defective seals.

Firm Action

Firm notified customer via telephone on 08/16/05.

Root Cause

Other

Distribution Pattern

Product distributed to one hospital located in FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K841959CARDIO METRIC CUSTOM PERFUSION TUBINGSterile Design, Inc. · 1984-10-19

Official Source

View FDA Recall →

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

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