Carefusion Safe-T Thora-Para Tray Recalled Due to Potential Air Leak
Carefusion 2200 Inc is recalling Safe-T 8 Fr Thora-Para Trays because internal valve leaks may introduce up to 30cc of air into patients.
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 is classified as FDA Class II, and the hazard involves the introduction of air into a patient, which is a risk-of-harm product where injury has not yet been explicitly reported in the source text.
Plain-English summary
Carefusion 2200 Inc is recalling the Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free. The recall is due to a defect where the Universal Drainage Set (UDS) may contain valves that leak internally. This malfunction may result in the introduction of up to 30cc of air into the patient.
The affected product is identified by Catalog TPT1000SDF and UDI 50885403108493. Specific batch numbers involved in the recall include 0001320515, 0001321729, 0001323273, 0001323703, 0001332819, 0001334405, 0001338453, 0001344142, and 0001344740. The agency has classified this as a Class II recall.
The product was distributed to 370 US customers and 13 distributors across numerous states, including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Healthcare facilities and distributors should check their inventory for the specific catalog and batch numbers listed and stop using the affected trays.
The recalled product
- Product
- Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free
- Manufacturer
- Carefusion 2200 Inc
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 (10)
- Catalog: TPT1000SDF UDI: 50885403108493
- Batches: 0001320515
- 0001321729
- 0001323273
- 0001323703
- 0001332819
- 0001334405
- 0001338453
- 0001344142
- 0001344740
Distribution
Part of a larger recall action
This product is one of 14 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · Carefusion 2200 Inc
See all →- HighEndoscopic surgical clamp recalled for defective rotation knob
FDA (Devices) · 2023-08-23
- HighSurgical Clamp Recall: Rotation Knob May Crack or Break
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob failure
FDA (Devices) · 2023-08-23
Same hazard · air embolism
See all →- HighFARADRIVE STEERABLE SHEATH CLEAR Medical Device Recall
FDA (Devices) · 2026-07-29
- SevereBoston Scientific Steerable Sheath Recalled Due to Potential Air Embolism Risk
FDA (Devices) · 2026-07-29
- HighFARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk
FDA (Devices) · 2026-07-29
- HighBoston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage
FDA (Devices) · 2026-07-29
- SevereMedical Angiographic Control Syringes Recalled for Rotating Adapter Risk
FDA (Devices) · 2026-05-20