RecallRadar

FDA Device recall Z-2687-2016

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

On 2016-09-07 the FDA classified a Class II recall of Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL by Baxter Healthcare, citing some of the individual extension set packages were improperly sealed, compromising the sterility of the product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2687-2016
ClassificationClass II
Statusterminated
Initiated2012-12-14
Published2016-09-07
Last updated2026-09-13 11:54 UTC
CompanyBaxter Healthcare
DistributionFL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, PR, SC, TN, TX, WV

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.

Reason

Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.

Identifiers

code_infoproduct code 2N3345, lot number UR12E03108

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2687-2016%22

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