Twelve French catheters with safety guard recalled over misleading securing instructions
Rocket Medical is recalling 240 Rocket 12Fg Seldinger Catheters with Safety Guard because the instructions and kit labeling contain misleading statements that can lead to improper securing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states misleading instructions can lead to a chest tube falling out during use, and no injuries are reported.
Plain-English summary
The Rocket 12Fg Seldinger Catheter with Safety Guard, model R54544-12-SG, is being recalled by Rocket Medical Plc. The product is a chest tube manufactured from PVC with fenestrations and a barium stripe.
The instructions for use and device kit labeling contain misleading statements leading to improper securing of the device, resulting in the potential for it to fall out during use.
The record lists 240 units carrying UDI-DI 050552709TF06DXY, across lot codes including 497012, 502660, 497561, 502780 and 497763. Domestic distribution covered Colorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina and Texas, with international distribution including the United Arab Emirates, Austria, Australia, Canada and Germany. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should follow Rocket Medical's instructions.
The recalled product
- Product
- Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplie
- Manufacturer
- Rocket Medical Plc
- Category
- Medical Device — Chest drainage
- Hazard
- misleading-instructions
- device-dislodgement
- chest-tube
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model/Catalog Number: R54544-12-SG
- UDI-DI: 050552709TF06DXY
- Lot Code: 497012
- 502660
- 497561
- 502780
- 497763
- 502978
- 498069
- 503202
- 499335
- 503384
- 499541
- 503406
- 499903
- 503536
- 500405
- 503733
- 500630
- 503900
Distribution
Distributed in 12 states:
- CO
- CT
- IL
- MA
- ME
- NH
- NJ
- NM
- OH
- RI
- SC
- TX
Related recalls
Same category
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22