OMNIPOD

General Hospital and Personal Use Devices

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Lot Numbers: L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250  Expanded Recall: Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: US (Nationwide) and country of: Switzerland.

OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208  Expanded Recall: Lot Codes: L41908, L41910, F41935

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: US (Nationwide) and country of: Switzerland.

OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.

OmniPod¿, Insulin Management System (US) || Catalog Number: PODZXP420 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.

Lot Codes: L41908, L41910, F41935

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.

OmniPod¿, Insulin Management System (OUS) || Catalog Number: 14810 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.