Devices

Device Recall OptiSeal Valved PTFE Peelable Introducer

Model / Serial
Model / lot number: 1000093-001 / W1515452; 1000093-002 / W1545383; 1000093-003 / W1519579, W1524143, W1515454; 1000093-004 / W1524146, W1519578, W1520649, W1515441; 1000093-005 / W1515455; 1000093-006 / W1515456; 1000093-007 / W1560536.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: United States, including the states of MN and CA.
Product Description
Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.
Manufacturer
Greatbatch Medical
1 Event
- Recall of Device Recall OptiSeal Valved PTFE Peelable Introducer

Manufacturer

Greatbatch Medical

Manufacturer Address
Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
Manufacturer Parent Company (2017)
Integer Holdings Corporation
Source
USFDA

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