Baxter Recalls Non-DEHP Y-Type Catheter Extension Sets Due to Sterility Compromise
Baxter Healthcare is recalling 228,200 units of Non-DEHP Y-Type Catheter Extension Sets because separating packages can compromise the sterile barrier of adjacent units.
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 risk-of-harm product (sterile barrier compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baxter Healthcare Corp. is recalling 228,200 units of Non-DEHP Y-Type Catheter Extension Sets (Product Code 2N3371). The affected lots are R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058, R12K17057, R12L10084, and R13A12057. These devices are indicated for blood sampling and the administration of solutions.
The recall was initiated after customers reported that when separating an individual package from its attached grouping, the adjacent package opened, compromising its sterile barrier properties. This defect poses a risk of contamination to the medical device.
The affected products were distributed worldwide, including the USA, Puerto Rico, Brazil, Canada, and Colombia. Healthcare facilities and consumers should stop using these specific lots and contact Baxter Healthcare for further instructions.
The recalled product
- Product
- A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection…
- Manufacturer
- Baxter Healthcare Corp.
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 (11)
- A) Product Code 2N3371: Lots R12H23076
- R12H30097
- R12I0707
- R12I08059
- R12I25046
- R12I2607
- R12J11052
- R12J12068
- R12J13058R12K17057
- R12L10084
- R13A12057
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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