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Terminated

ASY Brat 2 Procedure Set

FDA Recall Z-1073-05 · Posted 2005-08-03

Recalling FirmCobe Cardiovascular, Inc
Recall StatusTerminated
Product CodeCAC
Date Initiated2005-06-22
Date Terminated2006-07-27
Product Quantity56 units

Reason for Recall

Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.

Firm Action

Domestic customers were notified by overnight letter beginning 6/22/2005.Foreign consignees were notified by e-mail on 6/16-17/2005

Root Cause

Other

Distribution Pattern

Nationwide, including VA facilities in PA and WA. No other military or government consignees. Foreign distribution to Australia, Canada, Italy and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K933625BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEMCobe Cardiovascular, Inc. · 1993-12-29

Official Source

View FDA Recall →

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

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