Baxter IV Catheter Extension Set Recalled for Tubing Separation
Baxter Healthcare is recalling 66,800 units of ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Sets due to reports of tubing separation from the Male Luer Lock Adaptor.
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 is classified as FDA Class II, and the hazard involves a structural defect (tubing separation) in a medical device used for drug administration, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is recalling 66,800 units of the ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, REF 7N8370K. The recall is due to customer reports of separation between the tubing and the Male Luer Lock Adaptor. The product is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles.
The affected lots are DR18E01023, DR18E07053, DR19G08023, DR19H07015, DR19L09030, and DR20B04020. The distribution pattern includes worldwide distribution, specifically in the US states of SC, OH, MI, CA, and TX, as well as the UK and Ireland.
Healthcare facilities and consumers should stop using the affected products and contact Baxter Healthcare Corporation for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions…
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — IV Catheter
- Affected units
- 66,800
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 (13)
- UDI: 00085412613505
- Lot Numbers: DR18E01023
- exp. 5/2/2023
- DR18E07053
- exp. 5/8/2023
- DR19G08023
- exp. 7/8/2024
- DR19H07015
- exp. 8/7/2024
- DR19L09030
- exp. 12/10/2024
- DR20B04020
- exp. 2/5/2025
Distribution
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