Device Recall Epic

serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.

Ophthalmic Devices

1

No

US Nationwide Distribution

RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: || Product Usage: || Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.

Lot Numbers Version 6.20A  Cat. Number 442953

Clinical Chemistry and Clinical Toxicology Devices

1

No

15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors

EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . || Product Usage: || The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System that can manipulate and/or act upon AST results.

Catalog Number: 2111-0005 Lot: 51464

Orthopedic Devices

2

Yes

The products were distributed to the following US states: FL, PA, and VA.

Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)

Catalog Number: 2111-1010 Lot: 51461

Orthopedic Devices

2

Yes

The products were distributed to the following US states: FL, PA, and VA.

Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)

Serial numbers 0512068663, 0512068664, 0512068665, 0512068666, 0512068681, 0512068682, 0512068741, 0512068742, 0512068743, 0512068744, 0512068745, 0512068746, 0512068747, 0512068748, 0512068749, 0512068762, 0512068763, 0512068759, 0512068760, 0512068764, 0512068765, 0512068766, 0512068767, 0512068768, 0512068769, 0512068770, 0512068771, 0512068772, 0512068773, 0512068774, 0512068775, 0512068776, 0512068777, 0512068778, 0601085035, 0601085036, 0601085064, 0601085141, 0601085142, 0601085143, 0512068671, 0512068672, 0512068673, 0512068674, 0512068675, 0512068676, 0512068677, 0512068678, 0512068679 and 0512068680.

General Hospital and Personal Use Devices

2

No

World Wide--(Chile, Mexico and Singapore)

Stryker Epic Zoom Critical Care Bed; Model 2040.