Baxter Healthcare Corporation Recall 90848
Description: Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.
Baxter Healthcare Corporation Recall 90848 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0180-2023 |
| Event ID | 90848 |
| Event Description | Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures. |
| Product Type | Devices |
| Distribution | MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa |
| Quantity | 1 unit |
| Recall 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. |
| Device Classification | 20221109 |
| Device Code Info | UDI/DI 00615521012731, Lot Number: 22-124 |
| Center Classification Date | 20221103 |
| Recall Initiation Date | 20220920 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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