Baxter Non-DEHP Micro-Volume Extension Set Recalled for Sterility Compromise
Baxter Healthcare is recalling 15,257 units of Non-DEHP Micro-Volume Extension Sets because improper sealing compromised product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device where compromised sterility poses a risk of infection or harm to patients, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corp. is recalling 15,257 units of Non-DEHP Micro-Volume Extension Sets, Male Luer Lock Adapter, 36 inches (91 cm), with a volume of 0.32 mL. The affected product is identified by product code 2N3345 and lot number UR12E03108. These sterile, single-use, nonpyrogenic fluid pathways are intended for the administration of drugs and solutions to a patient's vascular system through a vascular access device.
The recall was initiated because some individual extension set packages were improperly sealed, which compromised the sterility of the product. The affected units were distributed worldwide, including in the United States (specifically Florida, Georgia, Illinois, Kansas, Kentucky, Michigan, Missouri, North Carolina, North Dakota, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and West Virginia), Puerto Rico, and Canada.
Healthcare facilities and consumers should stop using the affected extension sets immediately. Users should check their inventory for the specific product code and lot number listed above. If the product is found, it should be quarantined and returned to the supplier or Baxter Healthcare Corp. according to their instructions.
The recalled product
- 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…
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 15,257
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- product code 2N3345
- lot number UR12E03108
Distribution
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