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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0180-2023
Event ID90848
Event DescriptionSimple 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 TypeDevices
DistributionMI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
Quantity1 unit
Recall Reasonthe 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 Classification20221109
Device Code InfoUDI/DI 00615521012731, Lot Number: 22-124
Center Classification Date20221103
Recall Initiation Date20220920
Recalling FirmBaxter Healthcare Corporation
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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