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Recall Observatory FDA recall evidence

Device 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.

Z-2687-2016

December 14, 2012

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 63898
Status
Terminated
Classification
Class II
Quantity
15,257 units
Official record key
device-enforcement:Z-2687-2016

Official wording

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

Code information: product code 2N3345, lot number UR12E03108

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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