| Class 2 Device Recall Baxter FloThru | |
Date Initiated by Firm | December 06, 2023 |
Date Posted | January 05, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0663-2024 |
Recall Event ID |
93503 |
510(K)Number | K981624 |
Product Classification |
Clamp, vascular - Product Code DXC
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Product | Baxter Flo-Thru Intraluminal Shunt, Product Codes:
a) Product Code FT12100, 1.00 GLOBAL;
b) Product Code FT12125, 1.25 GLOBAL;
c) Product Code FT12150, 1.50 GLOBAL;
d) Product Code FT12175, 1.75 GLOBAL;
e) Product Code FT12200, 2.00 GLOBAL;
f) Product Code FT12225, 2.25 GLOBAL;
g) Product Code FT12250, 2.50 GLOBAL;
h) Product Code FT12275, 2.75 GLOBAL;
i) Product Code FT12300, 3.00 GLOBAL |
Code Information |
All serial numbers,
a) Product Code FT12100, UDI/DI 85412532431;
b) Product Code FT12125, UDI/DI 85412532448;
c) Product Code FT12150, UDI/DI 85412532455;
d) Product Code FT12175, UDI/DI 85412532462;
e) Product Code FT12200, UDI/DI 85412532479;
f) Product Code FT12225, UDI/DI 85412532486;
g) Product Code FT12250, UDI/DI 85412532493;
h) Product Code FT12275, UDI/DI 85412532509;
i) Product Code FT12300, UDI/DI 85412532516 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625
|
For Additional Information Contact | Center for One Baxter 800-422-9837 |
Manufacturer Reason for Recall | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI). |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Baxter issued an IMPORTANT PRODUCT INFORMATION to its consignees on 12/06/2023 via USPS first class mail. The notice explained the issue, potential hazard involved, and requested the following:
Actions to be Taken by Customers:
1. Healthcare providers may continue to safely use the products listed above while
following the associated Instructions for Use.
2. Cease any further distribution of the Cardiovascular Surgery marketing brochure
for the products listed above. All copies of this marketing brochure should be
promptly discarded. The brochure reference number, US-AS46-220001, can be
found at the bottom of the last page of the brochure.
3. If you received this communication directly from Baxter, please
acknowledge receipt by responding on our customer portal at
https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do
not have any inventory. Log in to the portal using the account number listed on
the enclosed reply form instruction sheet. Acknowledging receipt of this
notification will prevent you from receiving repeat notices. If you do not complete
the acknowledgement, you will receive a phone call from OnProcess Technology
on behalf of Baxter to confirm your receipt of this notification.
4. If you purchased this product from a distributor, please note that responding on
the Baxter customer portal is not applicable. If a response is requested by your
distributor or wholesaler, please respond to the supplier according to their
instructions.
5. If you distributed a copy of this brochure to other facilities or departments within
your institution, please forward a copy of this communication to them.
6. If you are a dealer, wholesaler, distributor/reseller, or original equipment
manufacturer (OEM) that distributed any copies of the brochure to other facilities,
please distribute this notification to customers and check the associated box on
the customer portal.
For general questions, contact Baxter Healthcare Center for Service at 888-229-0001,
betwe |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = DXC
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