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U.S. Department of Health and Human Services

Class 2 Device Recall Hillrom Welch Allyn Connex

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  Class 2 Device Recall Hillrom Welch Allyn Connex see related information
Date Initiated by Firm March 26, 2024
Date Posted April 10, 2024
Recall Status1 Open3, Classified
Recall Number Z-1511-2024
Recall Event ID 94295
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
Product Power Cords, marketed under the following models:
a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682;
b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010;
c) PLFM CLASS II POWER CORD - EUROPE, 716012;
d) POWER CORD,AUSTRALIA,2.5A,250V,2.5M,C7, 008-0910-00;
e) POWER CORD,EUROPEAN,2.5A,250V,2.5M,C7, 008-0912-00;
f) LINE CORD (EURO), 4500-402;
g) LINE CORD (UK), 4500-404;
h) LINE CORD (AUS), 4500-406
Code Information a) 714682, UDI/DI 732094121469; b) 716010, UDI/DI 732094119916; c) 716012, UDI/DI 732094119879; d) 008-0910-00, UDI/DI 732094033113; e) 008-0912-00, UDI/DI 732094033106; f) 4500-402, UDI/DI 732094004083; g) 4500-404, UDI/DI 732094004076; h) 4500-406, UDI/DI 732094004069
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		 Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Baxter issued an Urgent Medical Device Correction notice to its consignees on 03/26/2024 via USPS, first class mail. The notice explained the issue, hazard, and provided the following: Actions to be taken by customers: 1. Healthcare providers may continue to use the non-compliant power cords, but if any fraying or damage is observed, users should NOT make physical contact with the cord and discard the power cord immediately. 2. Healthcare providers should regularly inspect the power cords for fraying or other damage. 3. Once Baxter has replacement power cords, a follow-up notification will be sent with additional instructions on how to request replacement power cords. 4. Customers will be asked to acknowledge receipt of the Urgent Medical Device Correction notification by responding on our customer portal. 5. If the product has been distributed to other facilities or departments within the institution, customers will be asked to forward a copy of the Urgent Medical Device Correction notification to them. 6. If the customer is a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, they will be asked to notify their customers of this Urgent Medical Device Correction according to their customary procedures and check the associated box on the customer portal.
Quantity in Commerce 1338 cords
Distribution Global, US: NY, IL
Total Product Life Cycle TPLC Device Report
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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