Baxter Gambro Cartridge Blood Set Recalled for Tubing Disconnection Risk
Baxter Healthcare is recalling Gambro Cartridge Blood Sets due to a potential tubing disconnection hazard during hemodialysis treatment.
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 potential mechanical failure (tubing disconnection) in a medical device used for life-sustaining treatment. No injuries or illnesses have been reported, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling the Gambro Cartridge Blood Set Prime Line. The product is intended for single use in hemodialysis treatments using Dialysis Delivery Systems. The recall involves 2,361,885 units distributed worldwide, including nationwide distribution in the United States and in numerous countries across Europe, Asia, the Middle East, and the Americas.
The recall is being conducted because of a potential disconnection of the tubing set. This defect could occur during the hemodialysis treatment process. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and consumers who have these specific blood sets should stop using them immediately. The affected units are identified by specific lot numbers and product codes listed in the official recall documentation. Users should contact Baxter Healthcare Corporation for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 2,361,885
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)
- Product Code: 101025
- UDI: 37332414007837
- Lot Numbers: 1000200708
- 1000203117
- 1000203118
- 1000203119
- 1000203120
- 1000203121
- 1000205678
- 1000205897
- 1000205898
- 1000205899
- 1000205900
- 1000205901
- 1000206872
- 1000206873
- 1000206874
- 1000208247
- 1000208248
- 1000208249
Distribution
Part of a larger recall action
This product is one of 4 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.
See all 4 products in this recall →Related recalls
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