Surgical and Cardiovascular Device Marketing Brochures Recalled for Documentation Errors
Baxter Healthcare is recalling surgical and cardiovascular device marketing brochures that contain information conflicting with the official Instructions for Use. The inaccurate content could lead to incorrect device use.
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: This is a Class II medical device recall where marketing materials contain inaccurate information conflicting with the official Instructions for Use. While no injuries or illnesses have been reported, the potential for improper use of surgical and cardiovascular devices due to conflicting documentation constitutes a risk-of-harm product without yet-reported injury.
Plain-English summary
Baxter Healthcare Corporation is recalling marketing brochures for multiple surgical and cardiovascular devices. The affected products include the Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe.
The marketing brochures contain inaccurate information that does not align with the official Instructions for Use (IFU) for these devices. This mismatch could result in improper device use or application.
The recall affects approximately 112,760 units distributed worldwide, including throughout the United States, Canada, Ireland, United Kingdom, and Hong Kong. All affected product models and serial numbers are included in this recall.
Healthcare providers and facilities should immediately verify that marketing materials match the official Instructions for Use before using these devices. Contact Baxter Healthcare Corporation for corrected and accurate marketing materials.
The recalled product
- Product
- Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item…
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 112,760
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)
- US-AS18-210004 Surgical Tools Website v1
- and US-AS46-230002 CV Specialty Brochure US version
- Flo-Thru Intraluminal Shunt: ALL SERIAL NUMBERS: a) FT12100
- UDI/DI 00085412532004
- b) FT12125
- UDI/DI 00085412532011
- c) FT12150
- UDI/DI 00085412532042
- d) FT12175
- UDI/DI 00085412532059
- e) FT12200
- UDI/DI 00085412532066
- f) FT12225
- UDI/DI 00085412532073
- g) FT12250
- UDI/DI 00085412532080
- h) FT12275
- UDI/DI 00085412532097
- i) FT12300
- UDI/DI 00085412532103
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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