Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation.
FDA Recall Z-2138-2010 · Posted 2010-08-02
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Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeKPE
Date Initiated2010-05-26
Date Terminated2011-08-04
Product Quantity3,156,850 bags
Reason for Recall
Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
Firm Action
Consignees were notified by e-mail and Baxa Bag Product Notice letter on 05/26/2010 with instructions to not use any bags if the fill port cap is detached. Photos of a detached cap and properly attached cap were included. Defective bags could be returned to Baxa for credit. Information available at 800-678-2292.
Root Cause
Process design
Distribution Pattern
Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, China, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Pakistan, Panama, South Korea, Taiwan, United Kingdom, and Uruguay.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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