Fresenius Kabi CATSmart Autotransfusion Device Recalled for Tubing Wear Risk
Fresenius Kabi is recalling 342 CATSmart autotransfusion devices because tubing may contact the washing chamber, causing wear or puncture.
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: The recall involves a medical device with a risk of harm (tubing puncture) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Fresenius Kabi is recalling 342 units of the CATSmart device (Continuous autotransfusion System), including specific AT-1 and AT-3 autotransfusion sets and kits. The affected products are single-use disposable components used during surgery or trauma treatment to process autologous shed blood for reinfusion.
The recall was initiated after internal investigations identified events where the centrifuge tubing line may make contact with the washing chamber. This contact can result in excessive wear of the tubing or, in extreme cases, a puncture of the tubing.
The affected devices were distributed worldwide, including nationwide in the United States and in Canada. No specific illnesses or injuries are reported in the source text. Users should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Par
- Manufacturer
- Fenwal Inc
- Affected units
- 342
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)
- Product Code: 9005901
- Lot Numbers beginning with GM or H. Serial Numbers: 6CTA0209
- 6CTA0210
- 6CTA0211
- 6CTA0212
- 6CTA0213
- 6CTA0214
- 6CTA0215
- 6CTA0216
- 6CTA0217
- 6CTA0218
- 6CTA0219
- 6CTA0221
- 6CTA0222
- 6CTA0223
- 6CTA0224
- 6CTA0225
- 6CTA0226
- 6CTA0227
- 6CTA0228
Distribution
Related recalls
Same manufacturer · Fenwal Inc
See all →- HighAmicus MNC Apheresis Kit at Risk of Stress Leak in Centrifuge Packs
FDA (Devices) · 2023-03-22
- HighMedical Device Apheresis Kit Recalled Due to Stress Leak Risk
FDA (Devices) · 2023-03-22
- HighFenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks
FDA (Devices) · 2021-04-14
- SevereFenwal Recalls Amicus MNC Apheresis Kits Due to Centrifuge Pack Leaks
FDA (Devices) · 2021-04-14
- HighFenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks
FDA (Devices) · 2021-04-14
Same hazard · tubing puncture
See all →- SevereMedline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment
FDA (Devices) · 2024-01-03