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Terminated

Exacta-Mix Valve Set, Primary Valve Assembly

FDA Recall Z-0984-04 · Posted 2004-07-20

Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeLHI
Date Initiated2004-04-30
Date Terminated2004-08-12
Product Quantity1531 cases (10 per case)

Reason for Recall

A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.

Firm Action

Consignees were notified by phone, fax and letter beginning 4/30/2004.

Root Cause

Other

Distribution Pattern

Nationwide, including 6 military hospitals and two VA facilities. Foreign distribution to Argentina, Brazil, Canada, Columbia, Hong Kong, Korea, Malaysia, Mexico, Panama, Singapore, Taiwan, UK, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K900585TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMPBaxa Corp., Sub. of Cook Group, Inc. · 1990-04-18

Official Source

View FDA Recall →

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

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