Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1486-2021·Announced 2021-05-05

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.

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 2/5 (Moderate).

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…
Manufacturer: Cardiac Assist, Inc
Category: Medical Device — Cardiovascular
Hazard: mis-labeling
packaging-error
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

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Cardiac Assist, Inc

See all →

High
LifeSPARC Cardiac Pump Recalled Due to Uncured Epoxy Manufacturing Defect
FDA (Devices) · 2023-09-06
Severe
Medical device controller software update addresses critical failure
FDA (Devices) · 2023-01-25
Severe
TANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide
FDA (Devices) · 2022-10-05
Moderate
Cardiac Assist Procedure Kit Recalled for Incorrect Expiration Date Label
FDA (Devices) · 2021-12-08
High
Cardiac Assist Recalls 15 TandemHeart Pumps Due to Assembly Error
FDA (Devices) · 2020-05-20

Same hazard · mis labeling