Insulet Corporation: Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

Recall number

Z-1203-2021

Recalling firm

Insulet Corporation

Product

Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

Status

Terminated

Initiated

2021-02-01

Posted

not on file

Terminated

2023-02-08

Reason

Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the period as a decimal separator when entering a bolus value, this decimal separator would not be recognized by the device and any numbers entered after the period could result in a larger value than intended

Root cause

Labeling design

Action

Insulet issued Email, mail, or outbound call notification of the Field Safety Notification between Feb 2nd and Feb 5 th to end customers, HCPs and distributors in: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland. Letter states reason for correction, health risk and action to take: Please refer to the attached Annex in reference to page 6 of the User Guide as opposed to referring to the instructions in the existing User Guide. We recommend you place this insert at p.6 in your User Guide. Please ensure that the comma is always used when entering bolus values. In accordance with applicable rules, this corrective action is implemented with the knowledge of the relevant competent authorities. Please electronically confirm your understanding of this Field Safety Notification by going to the webpage the link below and following the instructions on screen.

Quantity

21,723 guides

Distribution

Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

Lot, serial or model codes

Part Number/Rev./Country: PT 000002 AUT DEU mg 1, 2, 3 Guide, Dash User, German Austria PT 000002 BEL DEU MG 1, 2, 3 Guide, Dash User Guide, Belgium  Germany, mgdl PT 000002 BEL FRE MG 1, 2, 3, 4 Guide, Dash User Guide, Belgium French, mgdl PT 000002 BEL NLD MG 1, 2, 3 Guide, Dash User Guide, Belgium Dutch, mgdl PT 000002 DEU DEU mg 1, 2, 3 Guide, Dash User Guide, German  Germany, mgdl PT 000002 DEU DEU mm 1, 2, 3 Guide, Dash User Guide, German  Germany, mmoll PT 000002 DNK DANmm 1, 2, 3 Guide, Dash User Guide, Danish Denmark PT 000002 FIN FIN mm 1, 2, 3 Guide, Dash User Guide, Finnish Finland PT 000002 FRA FRE mg 1, 2, 3, 4 Guide, Dash User Guide, French France PT 000002 NLD NLD mm 1, 2, 3, 4 Guide, Dash User Guide, Dutch  Netherland PT 000002 NOR NORmm 1, 2, 3 Guide, Dash User Guide, Norwegian  Norway PT 000002 SWE SWEmm 1, 2, 3 Guide, Dash User Guide, Swedish Sweden 41333 CAN 1, 2 User Guide, Omnipod, Dash, Canada PT 000318 1, 2 Guide, Dash User Guide, Greece PT 000319 1, 2 Guide, Dash User Guide, Turkey

510(k) numbers

["K192659"]

PMA numbers

not on file

Product code

LZG

Firm FEI

3014585508

Firm city

Acton

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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