Gambro Cartridge Blood Sets Recalled Due to Occluded Heparin Tubing
Gambro Renal Products is recalling specific Gambro Cartridge Blood Sets because occluded heparin tubing may prevent anticoagulation dosing during hemodialysis.
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 functional defect (occluded tubing) that prevents anticoagulation dosing, which poses a risk of harm to patients during hemodialysis, but the source does not report specific injuries or hospitalizations, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Gambro Cartridge Blood Sets, which are single-use sterile tubing sets used for extracorporeal blood transport during hemodialysis. The recall affects Model Numbers 101025 and 103401. The issue involves occluded heparin tubing events that can prevent the proper dosing of anticoagulation medication during treatment.
The recall covers 306,525 sets, distributed in 20,435 boxes of 15 sets each. These products were distributed nationwide in the United States, as well as in Canada, Mexico, and Colombia. The affected lot numbers are 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, and 1000075553.
Healthcare facilities and patients using these specific Gambro Cartridge Blood Sets should stop using the affected units and contact Gambro Renal Products for further instructions or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extrac
- Manufacturer
- Gambro Renal Products, Incorporated
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)
- Lot number: 1000039228
- 1000048340
- 1000050644
- 1000050648
- 1000054032
- 1000058516
- 1000064913
- 1000065817
- 1000065823
- 1000066430
- 1000063347
- 1000067984
- 1000068071
- 1000071417
- 1000071430
- 1000073434
- 1000073436
- 1000073438
- 1000074660
- 1000074661
Distribution
Distributed nationwide across the United States.
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