Recall Z-0175-2023 ยท GDC Table, Operating-Room, Electrical
Baxter Healthcare Corporation
Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
| Date | Nov 3, 2022 (initiated Sep 20, 2022) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 t |
| Quantity | 2 units |
| Distribution | MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.