Product Safety Recalls

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Aspen Surgical Products, Inc. Recall 88476

Description: Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400

Aspen Surgical Products, Inc. Recall 88476 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2390-2021
Event ID88476
Event DescriptionNorton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Product TypeDevices
DistributionUS nationwide distribution. No foreign distribution.
Quantity124
Recall ReasonAffected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Device Classification20210908
Device Code InfoAll lots manufactured between July 9, 2019 to July 9, 2021
Center Classification Date20210830
Recall Initiation Date20210723
Recalling FirmAspen Surgical Products, Inc.
Initial Notification Letter
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