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Mahurkar Chronic Catheter (Covidien) – Hub Leakage Risk (2022)

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

FDAJun 8, 2022Nationwide• Covidien Llc

Palindrome Precision Chronic Catheter (Covidien) – Hub Leakage Risk (2022)

FDAJun 8, 2022Nationwide• Covidien Llc

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Mahurkar Chronic Catheter (Covidien) – Hub Leakage Risk (2022)

Palindrome Precision Chronic Catheter (Covidien) – Hub Leakage Risk (2022)

Palindrome HSI Chronic Catheter (Covidien) – Hub Leakage Risk (2022)

Palindrome Precision H Chronic Catheter (Covidien) – Potential Hub Leakage (2022)

Palindrome Precision SI Chronic Catheter (Covidien) – Potential Hub Leakage (2022)

Palindrome Chronic Catheter (Covidien) – Potential Hub Leakage (2022)

TruClear Hysteroscopic Tissue Removal System (Covidien) – Control Unit Failure (2022)

HydroSurg Plus Laparoscopic Irrigator (Davol) – Irrigation Failure (2022)

Venous Access Pack (Medline) – Isopropyl Alcohol Leak (2022)

Lap Chole Kit (Medline) – Isopropyl Alcohol Leak (2022)

Convenience Kits (Medline) – Isopropyl Alcohol Leak (2022)

Medical Kit (Medline) – Isopropyl Alcohol Leak (2022)

Custom Procedural Kits (Medline) – Isopropyl Alcohol Leak (2022)

Polypectomy Snare (Hobbs Medical) – Sheath Kinking Risk (2022)

VivaSight 2 DLT (Ambu) – Cuff Leak Risk (2022)

Trevo Trak Microcatheter (Stryker) – Carton Label Omission (2022)

INFINITY Resect Guide (Wright Medical) – Incorrect Color Coding (2022)

CT/PET/NM Table (GE Healthcare) – Potential Table Drop (2022)

Vivo 45LS Ventilator (Breas) – Processor Shutdown Risk (2022)

GCX Channel Mounting Accessory (Skytron) – Mounting Screw Problem (2022)