Cardiac Assist Recalls Incorrectly Packaged Protek Solo Venous Dilator Sets
Cardiac Assist, Inc. is recalling 13 Protek Solo Venous Dilator Sets due to incorrect packaging discovered in finished goods.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as incorrect packaging without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardiac Assist, Inc. is recalling 13 kits of Protek Solo Venous Dilator Sets, including LS Tandem Life Kits and ProtekSolo Venous Dilator Sets. The recall was initiated after it was discovered on February 26, 2021, that dilator sets were incorrectly packaged in finished goods.
On March 1, 2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field. The affected products were distributed nationwide in the states of Alabama, Arizona, Illinois, and Tennessee. Specific lot and serial numbers are listed in the agency's recall record.
Healthcare facilities and distributors should stop using the affected kits and contact Cardiac Assist, Inc. for instructions on return or replacement. Consumers who have purchased these specific medical devices should contact their healthcare provider or the manufacturer for guidance.
The recalled product
- Product
- Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous
- Manufacturer
- Cardiac Assist, Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 13
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)
- LOT/SERIAL: 285586
- 00145202
- 00145204
- 00871587
- 00871549
- 00871560
- 00871561
- 00871562
- 00871563
- 00871564
- 00871565
- 00871566
- 00871567
Distribution
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