Z-2144-2010

Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341...

Name: Z-2144-2010 Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341...
Creator: Baxa Corporation
Published: 2010-05-26
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2010-05-26 / Terminated / root cause: manufacturing process

FDA source

Baxa Corporation began a recall of Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341, Baxa Corporation on 2010-05-26. The reason FDA records is "Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2144-2010
Status: Terminated
Initiated: 2010-05-26
Posted: 2010-08-02
Terminated: 2011-08-04
Recalling firm: Baxter Corporation Englewood
Product: Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341, Baxa Corporation.
Product code: KPE Container, I.V.
Reason for recall: Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 67,800 bags
Distribution: 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.
Product codes and lots: All lot numbers

Product code KPE

K900585Class IITubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. / cleared 1990-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)