Baxter Gambro Cartridge Single Needle Conversion Kit Recalled for Kinked Lines
Baxter Healthcare is recalling Gambro Cartridge Single Needle Conversion Kits due to reports of kinked access lines during hemodialysis treatments.
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 involves a risk-of-harm product (hemodialysis equipment) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 385 units of the Gambro Cartridge Single Needle Conversion Kit, product code 101290. These devices are intended for single use in hemodialysis treatments using the Phoenix Dialysis Delivery Systems. The recall covers all lots within expiry, identified by UDI 07332414007881.
The recall was initiated after complaints were received regarding kinked access lines observed during treatment using the cartridge sets. The agency has classified this as a Class II recall. The products were distributed worldwide.
Healthcare providers and patients should stop using the affected devices immediately. Users should contact Baxter Healthcare Corporation for further instructions on how to return the products or obtain replacements.
The recalled product
- Product
- Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 385
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)
- UDI 07332414007881
- All lots within expiry
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Baxter Healthcare Corporation 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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