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FDA (Device enforcement)Recalled 2020-05-28closedclass ii

Carefusion 2200 Inc: Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine

Is my product affected?

Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine

  • UPC 50885403231900

Check against the official notice below — it lists the full affected range.

What happened

Carefusion 2200 Inc. has recalled the Thora-Para 8 Fr Catheter Drainage Tray without Lidocaine due to a defect in the Universal Drainage Set (UDS). The UDS may contain valves that leak internally, potentially allowing up to 30 cubic centimeters of air to enter a patient. The product was distributed to 370 U.S. customers and 13 distributors across all states and Puerto Rico.

The affected product carries catalog number TPT1000CDF, UDI 50885403231900, and batch number 0001333309. The recall notice does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Details from the source

Reason for recall: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Distribution: 370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, 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, WY Customer listed, including Federal distribution, uploaded. Quantity: N/A Lot/code info: Catalog: TPT1000CDF UDI: 50885403231900; Batch 0001333309

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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