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U.S. Department of Health and Human Services

Class 2 Device Recall Allen Advance Table

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  Class 2 Device Recall Allen Advance Table see related information
Date Initiated by Firm September 20, 2022
Date Posted November 03, 2022
Recall Status1 Open3, Classified
Recall Number Z-0175-2023
Recall Event ID 90848
Product Classification Table, operating-room, electrical - Product Code GDC
Product Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
Code Information a) UDI/DI 00615521003012, Serial Number 122190000035, Lot Number 122220000528 b) UDI/DI 00615521003036, Serial Number 122230000655, Lot Number 122180001460
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		 the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
FDA Determined
Cause 2		 Other
Action The firm issued an Urgent Medical Device Correction notice to their consignee on 09/20/2022 by email. The notice explained the problem, risk, and requested the following: "Actions to be taken by Customer: 1. Identify the impacted lot number listed on page 1 and stop any use of the product immediately. 2. Hillrom will contact you to perform a correction of your impacted device as soon as possible." The firm issued an Urgent Medical Device Recall notice to their consignees on 09/27/2022 by FedEx 2nd day delivery. The notice explained the problem, risk, and requested the following: "Actions to be taken by Customer: 1. Identify the impacted lot numbers listed in the above table and replace with the enclosed device that accompanies this notification. 2. Please return the impacted unit per RMA instructions attached within 10 business days. Actions to be taken by Distributor: 1. Please forward this notification to your end users along with replacement parts accompanying this notification. 2. Please request return of the impacted devices from your end users and return the devices to Hillrom, per RMA instructions attached." Both notices provided the following contact information: "Contact reference person If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at 800-445-3720 or technical.support@hillrom.com"
Quantity in Commerce 2 units
Distribution MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
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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