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