Carefusion Thora-Para Catheter Drainage Tray Recalled for Internal Valve Leaks
Carefusion 2200 Inc is recalling Thora-Para 8 Fr Catheter Drainage 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. The hazard involves the introduction of air into the patient, which is a risk-of-harm scenario where specific injury reports are not detailed in the source text, fitting the criteria for a High severity score.
Plain-English summary
Carefusion 2200 Inc is recalling the Thora-Para 8 Fr Catheter Drainage Tray (Catalog: TPT1000) due to a defect in the Universal Drainage Set (UDS). The UDS may contain valves that leak internally, which may result in the introduction of up to 30cc of air into the patient.
The recall affects 370 US customers and 13 distributors. The product was distributed across 48 states and Puerto Rico, including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming. Specific batch numbers are listed in the agency record.
Healthcare facilities and distributors should stop using the affected devices and contact Carefusion 2200 Inc for further instructions on the recall process.
The recalled product
- Product
- Thora-Para 8 Fr Catheter Drainage Tray
- Manufacturer
- Carefusion 2200 Inc
- Category
- Medical Device — Catheter
- Hazard
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)
- Catalog: TPT1000 UDI: 50885403108486
- Batches: 0001319053
- 0001319438
- 0001320227
- 0001320514
- 0001321276
- 0001321497
- 0001322638
- 0001322905
- 0001323536
- 0001323775
- 0001332576
- 0001334403
- 0001334406
- 0001335268
- 0001335696
- 0001336965
- 0001338449
- 0001338788
- 0001338789
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.
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