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Dutch Ophthalmic USA, Inc. Recall 88162

Description: The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201.

Dutch Ophthalmic USA, Inc. Recall 88162 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2252-2021
Event ID88162
Event DescriptionThe device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201.
Product TypeDevices
DistributionUS Nationwide Distribution in the states of AL, CA, CO, FL, MI
Quantity16 boxes
Recall ReasonLabeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Device Classification20210818
Device Code InfoLot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
Center Classification Date20210812
Recall Initiation Date20190521
Recalling FirmDutch Ophthalmic USA, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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