Baxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk
Baxter Healthcare is recalling 19,800 Gambro Cartridge Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.
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 involves a medical device with a potential mechanical failure (tubing disconnection) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 19,800 units of the Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set. The recall is due to a potential disconnection of the tubing set. The product is intended for single use in hemodialysis treatments using Dialysis Delivery Systems.
The affected product has been distributed worldwide, including nationwide in the United States and in numerous international countries. Specific lot numbers involved in the recall are 1000201510, 1000206870, 1000214235, 1000218202, and 1000224530. The product code is 114434 and the UDI is 47332414112395.
Healthcare facilities and users should stop using the affected blood transport systems and contact Baxter Healthcare Corporation for further instructions on the recall.
The recalled product
- Product
- Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 19,800
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 (7)
- Product Code: 114434
- UDI: 47332414112395
- Lot Numbers: 1000201510
- 1000206870
- 1000214235
- 1000218202
- 1000224530
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.
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