United StatesMAHURKAR Acute High Pressure Triple Lumen Catheter Tray curved and straight extensions with IC components (12 Fr/Ch, 4.0 mm; lengths 13 cm, 16 cm, 20 cm, 24 cm) sold under REF 8888101001HP, 8888101002HP, 8888101003HP, 8888102003HP, 8888102004HP, and 8888104004HP (multiple UDI-DI and lot numbers). They were recalled because of a potential issue with the seal integrity of the header bag packaging; the recall was distributed nationwide in the United States.
What's being recalled
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Recalling firm: Mozarc Medical US LLC, Mansfield, MA, United States.
How to identify it
REF Number: 8888101001HP; UDI-DI: (Individual unit) 10884521127890, (Carton) 20884521127897; Lot number: 2430500021 REF Number: 8888101002HP; UDI-DI: (Individual unit) 10884521127968, (Carton) 20884521127965; Lot number: 2430500017; REF Number: 8888101003HP; UDI-DI: (Individual unit) 10884521127975, (Carton) 20884521127972; Lot number: 2424500194, 2430500018; REF Number: 8888102003HP; UDI-DI: (Individual unit) 10884521127999, (Carton) 20884521127996; Lot number: 2418000195; REF Number: 8888102004HP; UDI-DI: (Individual unit) 10884521128002, (Carton) 20884521128009; Lot number: 2424500197; REF Number: 8888104004HP; UDI-DI: (Individual unit) 10884521832817, (Carton) 20884521128061; Lot number: 2427800166;
The hazard
A potential issue with the seal integrity of header bag packaging.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)