Z-0663-2024Class II
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code...
Baxter Healthcare Corporation / initiated 2023-12-06 / Open, Classified / root cause: labeling and UDI
Baxter Healthcare Corporation began a recall of 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... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0663-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Baxter Healthcare Corporation
- 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
- Product code
- DXC Clamp, Vascular
- 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).
- Root cause tag
- labeling and UDI
- FDA root cause
- 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.
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0656-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0657-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0658-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0659-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0660-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0661-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0662-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0663-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0664-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0665-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0666-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0667-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0668-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0669-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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