Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise
Baxter Healthcare is recalling specific lots of Non-DEHP catheter extension sets because separating packages can compromise the sterile barrier of adjacent units.
What this means for you
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 is classified as FDA Class II. The hazard involves a compromised sterile barrier, which poses a risk of infection (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 specific lots of Non-DEHP Y-Type and I.V. Catheter Extension Sets. The recall involves Product Code 2N1191 (53,850 units) and Product Code 2N1206 (101,900 units). These devices are indicated for use with a vascular access device for the administration and withdrawal of fluids.
The recall was initiated after customers reported that when separating an individual package from its attached grouping, the adjacent package opened. This action compromised the sterile barrier properties of the adjacent package. The affected lots were distributed worldwide, including the United States, Puerto Rico, Brazil, Canada, and Colombia.
Healthcare facilities and consumers should stop using the affected product codes and lot numbers listed in the recall notice. Users should contact Baxter Healthcare Corp. for further instructions on how to return or dispose of the recalled devices.
The recalled product
- Product
- A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only P
- 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 (12)
- A) Product Code 2N1191: Lots R12J06052
- R12J08041
- R12K06134
- R12K08015
- R12K26108
- R12K27155
- B) Product Code 2N1206: Lots R12J08124
- R12J24121
- R12K01119
- R12K23089
- R12K24053
- R12K22016
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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