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Infusion Safety Products, Inc.

INFUSION SAFETY PRODUCTS, INC. · Model ISP1915Y · UDI-DI 00856673008153

PTI Prescription
1
510(k) clearances
157
Adverse events
12
Recalls
33
Facilities

Description

19ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

Recalls

DateFirmReason
2020-06-19Becton Dickinson & CompanyPotential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19Becton Dickinson & CompanyPotential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19Becton Dickinson & CompanyPotential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19Becton Dickinson & CompanyPotential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19Becton Dickinson & CompanyPotential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19Becton Dickinson & CompanyPotential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19Becton Dickinson & CompanyPotential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19Becton Dickinson & CompanyPotential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19Becton Dickinson & CompanyPotential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19Becton Dickinson & CompanyPotential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.