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FlexDex Inc. Recall 89316

Description: 8mm FlexDex Needle Driver, Product Code FD-335 ND

FlexDex Inc. Recall 89316 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0531-2022
Event ID89316
Event Description8mm FlexDex Needle Driver, Product Code FD-335 ND
Product TypeDevices
Recall ReasonThe firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
Device Classification20220202
Device Code InfoAll lots
Center Classification Date20220127
Recall Initiation Date20211222
Recalling FirmFlexDex Inc.
Initial Notification Letter
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