ALLEN recallZ-0175-2023 · Baxter Healthcare Corporation · initiated Sep 20, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Other
What the company is doing
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 [email protected]"
Recall details
- Recall number
- Z-0175-2023
- Status
- Terminated
- Initiated by the company
- Sep 20, 2022
- Posted by the FDA
- Nov 3, 2022
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 2 units
- Product code
- GDC
- Distribution
- MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
Product description
Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
Code information (models, lots, serial numbers)
a) UDI/DI 00615521003012, Serial Number 122190000035, Lot Number 122220000528 b) UDI/DI 00615521003036, Serial Number 122230000655, Lot Number 122180001460
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ALLEN 107003Hill-Rom, Inc. · Table, operating-room, electrical1 recall9 reports
- ALLEN 107003Hill-Rom, Inc. · Table, operating-room, electrical1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90848).
- Z-0176-2023 · TerminatedC-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
- Z-0179-2023 · TerminatedAllen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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