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Terminated

Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.

FDA Recall Z-1030-2010 · Posted 2010-03-09

Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeKPE
Date Initiated2009-11-12
Date Terminated2011-02-24
Product Quantity646/50 bag cases

Reason for Recall

TPN bags may leak fluid due to inadequate sealing.

Firm Action

Consignees were notified by Baxa Urgent Exactamix Bag Recall letter on 11/12/2009 and then again on 11/17/2009 when more lots were found to be affected. Instructions were to stop use and return all affected product to Baxa. More information is available at 800-678-2292.

Root Cause

Process control

Distribution Pattern

Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay.

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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