Soft PVC Thoracic Catheters
This recall involves thoracic catheters manufactured for use in draining fluid or air from the chest cavity.
See the official recall notice for details about this consumer action.
Why it was recalled
This recall involves thoracic catheters manufactured for use in draining fluid or air from the chest cavity. The affected catheters may contain white particulate matter, which can block the catheter lumen and potentially restrict the flow of the drainage. If such a blockage occurs during use, the patient may not receive the intended treatment effect, and if the particulate matter enters the body, it could cause serious adverse health consequences. Users are advised to stop using the affected product immediately and contact the manufacturer for a replacement.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Getinge PVC Thoracic Catheter
| Product | Lot code | UDI-DI |
|---|---|---|
| Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036); | ME244878, ME244835, ME244682, ME244836, ME244837, ME244681, ME244840, ME244686 | 00650862130164, 00650862130249, 00650862130287, 00650862130324, 00650862130362 |
| Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136); | ME244852, ME244854, ME244855, ME244565, ME244858, ME244859, ME244861 | 00650862132243, 00650862132281, 00650862132328, 00650862132366 |
| Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036); | ME244891, ME244850 | 00650862150285, 00650862150360 |
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Failed Specifications recalls
Editorial summary by Recall Canary · summary updated 2026-09-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification