Baxter Recalls Non-DEHP Y-Type Catheter Extension Set Kits
Baxter Healthcare is recalling 513,000 units of IV extension tubing kits because separating packages can compromise the sterile barrier.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a compromised sterile barrier without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Baxter Healthcare Corp. is recalling 513,000 units of Non-DEHP Y-Type Catheter Extension Set Kits (Product Code 2N8371). The recall involves specific lots distributed worldwide, including the United States, Puerto Rico, Brazil, Canada, and Colombia.
The recall was initiated after customers reported that separating an individual package from its attached grouping caused the adjacent package to open. This action compromises the sterile barrier properties of the affected packages.
Healthcare facilities and users should stop using the affected product codes and lots immediately. Baxter Healthcare is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the…
- 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 (20)
- A) Product Code 2N8371: Lots R12E03108
- R12H27085
- R12H28075
- R12H29057
- R12H30139
- R12103092
- R12104058
- R12105022
- R12106061
- R12110113
- R12119056
- R12120112
- R12121151
- R12122050
- R12124106
- R12124130
- R12J25045
- R12K03057
- R12K19046
- R12K21034
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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