Z-0023-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2023
- Initiation Date
- July 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1170 units
Product Description
Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
Reason for Recall
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Distribution Pattern
US Nationwide distribution in the state of Indiana.
Code Information
GTIN 08714729283539, Lot/Batch Numbers: 26409983, 26590809, 27450921, 27780468, 25715223, 25761249, 25964483, 25964484, 26138315, 26409984, 26891844, 27558598, 27780463, 28632343, 28737896