Z-2687-2016Class II

Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx...

Name: Z-2687-2016 Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx...
Creator: Baxter Healthcare Corp.
Published: 2012-12-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2012-12-14 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets... on 2012-12-14. FDA classified it as Class II and gives the reason as "Some of the individual extension set packages were improperly sealed, compromising the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2687-2016
Classification: Class II
Status: Terminated
Initiated: 2012-12-14
Posted: 2016-08-29
Terminated: 2016-12-23
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: Baxter sent an Urgent Product Recall notification letter dated December 14, 2012, to all affected customers. Baxter instructed customers to locate and remove all affected product from their facility. Customers were instructed to contact Baxter Healthcare Center for Service to arrange for return of product and credit and to complete the attached Customer Reply Form and return it to Baxter or scanned email. Customers with questions should call 1-888-229-0001. For questions regarding this recall call 800-422-9837.
Quantity in commerce: 15,257 units
Distribution: Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally to Canada.
Product codes and lots: product code 2N3345, lot number UR12E03108

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2687-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2687-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-29

Product code FPA

K042936Class IISolution Administration with Luer Access Injection SiteBaxter Healthcare Corp / cleared 2004-11-26

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)