Baxter Non-DEHP Micro-Volume Extension Set recall: Sterility Concern
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…
Why was Baxter Non-DEHP Micro-Volume Extension Set recalled?
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
product code 2N3345, lot number UR12E03108
- 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…
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 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.
- Recall date
- September 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)