Twelve French chest tube trays recalled over misleading securing instructions
Rocket Medical is recalling 635 Rocket 12Fg Seldinger Catheter Procedure Trays 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 Procedure Tray, model R54544-12-PK, 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 635 units carrying UDI-DI 050552709TF06DXY, across lot codes including 496708, 501186, 496903, 501548 and 497147. 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 Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to
- 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-PK
- UDI-DI: 050552709TF06DXY
- Lot Code: 496708
- 501186
- 496903
- 501548
- 497147
- 502122
- 497292
- 502317
- 497344
- 502534
- 497664
- 502949
- 499226
- 503201
- 499276
- 503429
- 499415
- 503732
Distribution
Distributed in 12 states:
- CO
- CT
- IL
- MA
- ME
- NH
- NJ
- NM
- OH
- RI
- SC
- TX
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