Carefusion Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray Recalled for Leaking Valves
Carefusion 2200 Inc is recalling Safe-T-Centesis PLUS 6 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 potential introduction of air into the patient, which is a risk-of-harm scenario where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Carefusion 2200 Inc is recalling the Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray (Catalog: PIG1260TSP) 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 affected product was distributed to 370 US customers and 13 distributors across multiple 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. Specific batch numbers affected include 0001319377, 0001321496, 0001324092, 0001333971, 0001335442, 0001336583, 0001336964, 0001338981, 0001343845, 0001344649, and 0001346293.
Healthcare facilities and distributors should check their inventory for the specific catalog number and batch numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have used this device should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
- 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 (12)
- Catalog: PIG1260TSP UDI: 50885403108387
- Batches: 0001319377
- 0001321496
- 0001324092
- 0001333971
- 0001335442
- 0001336583
- 0001336964
- 0001338981
- 0001343845
- 0001344649
- 0001346293
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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