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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Carefusion 2200 Inc: 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.

Agency Publication Date: July 20, 2020
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Affected Products

Product: Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

Catalog: OTP5000; UDI: 50885403284746; Batches 0001319437, 0001320128, 0001321277, 0001321728, 0001322907, 0001324316, 0001332577, 0001334404, 0001335108, 0001336587, 0001337314, 0001338451, 0001339415, 0001341205, 0001342585, 0001344650, 0001346669, 0001346992

Product: Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

Catalog: OTP5000SP; UDI: 50885403284746; Batch 0001337784

Lot Numbers:
0001337784
Product: Safe-T-Centesis 6 Fr Catheter Drainage Tray

Catalog: PIG1260T; UDI: 50885403108363; Batches: 0001319266, 0001320359, 0001320361, 0001321495, 0001321903, 0001322646, 0001323766, 0001324093, 0001324318, 0001331342, 0001332814, 0001332817, 0001333972, 0001335443, 0001335444, 0001335695, 0001336580, 0001336581, 0001336582, 0001336962, 0001336963, 0001337307, 0001337983, 0001338432, 0001338452, 0001339413, 0001339782, 0001339783, 0001341546, 0001342258, 0001342587, 0001343637, 0001343638, 0001344743, 0001346287, 0001346479, 0001346480

Product: Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine

Catalog: PIG1260TCDF UDI: 50885403231894; Batches 0001335833 and 0001341627

Product: Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray

Catalog: PIG1260TSP UDI: 50885403108387; Batches: 0001319377, 0001321496, 0001324092, 0001333971, 0001335442, 0001336583, 0001336964, 0001338981, 0001343845, 0001344649, 0001346293

Product: Safe-T-Centesis 8 Fr Catheter Drainage Tray

Catalog: PIG1280T UDI: 50885403108400; Batches: 0001320864, 0001321078, 0001333781, 0001335698, 0001336588, 0001337539, 0001341632, 0001345260

Product: Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray

Catalog: PIG1280TSP UDI: 50885403108424; Batches: 0001320865, 0001321079, 0001333154, 0001333780, 0001335440, 0001338450, 0001341635

Product: Thora-Para 8 Fr Catheter Drainage Tray

Catalog: TPT1000 UDI: 50885403108486; Batches: 0001319053, 0001319438, 0001320227, 0001320514, 0001321276, 0001321497, 0001322638, 0001322905, 0001323536, 0001323775, 0001332576, 0001334403, 0001334406, 0001335268, 0001335696, 0001336965, 0001338449, 0001338788, 0001338789, 0001339414, 0001339562, 0001341206, 0001341633, 0001342263, 0001343223, 0001343636, 0001344137, 0001346668, 0001346670, 0001346671

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

Catalog: TPT1000CDF UDI: 50885403231900; Batch 0001333309

Lot Numbers:
0001333309
Product: Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free

Catalog: TPT1000SDF UDI: 50885403108493; Batches: 0001320515, 0001321729, 0001323273, 0001323703, 0001332819, 0001334405, 0001338453, 0001344142, 0001344740

Product: Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray

Catalog: TPT1000SP UDI: 50885403108431; Batches: 0001319836, 0001320129, 0001321726, 0001321727, 0001322906, 0001323275, 0001324091, 0001324317, 0001333308, 0001333777, 0001334187, 0001335697, 0001337779, 0001337982, 0001341544, 0001342586, 0001344739, 0001346286

Product: Thora-Para 5 Fr Catheter Drainage Tray

Catalog: TPT1005 UDI: 50885403220850; Batches: 0001320127, 0001323274, 0001333152, 0001335109, 0001339556, 0001345011

Product: Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free

Catalog: TPT1005SDF UDI: 50885403228139; Batches: 0001333153 and 0001339557

Product: Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray

Catalog: TPT1005SP UDI: 50885403220867; Batch: 0001345010

Lot Numbers:
0001345010

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85751
Status: Resolved
Manufacturer: Carefusion 2200 Inc
Manufactured In: United States

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.