Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Softwa
FDA device recall Z-0952-2026 · posted 2025-12-18 · Open, Classified
Recall details
- Recalling firm
- Rocket Medical Plc
- Reason for recall
- IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
- Action taken
- On November 12, 2025, Urgent Medical Device Correction Letters were sent to customers. Actions to be taken: 1. Ensure a copy of this letter and the updated IFU are available to all users or potential users of this device. 2. Complete the FSN acknowledgement form and return via the email provided.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- GBX
- Quantity affected
- 630 units
- Distribution
- Domestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX; International: UAE, Austria, Australia, Canada, Germany, Denmark, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India,
- Date initiated
- 2025-11-07
- Date posted
- 2025-12-18
- Location
- United Kingdom
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