Animas Vibe Insulin Pump Recalled for Incorrect Hebrew Translation
Animas Corporation is recalling 1,028 Vibe Insulin Infusion Pumps in Israel due to incorrect Hebrew language translations and omitted text on the display screen.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is incorrect labeling/translation leading to potential confusion, which aligns with the 'Moderate' criteria for labeling errors without reported serious injury.
Plain-English summary
Animas Corporation is recalling 1,028 units of the Vibe Insulin Infusion Pump. The recall is limited to international distribution in Israel. The product is indicated for the continuous subcutaneous infusion of insulin for the treatment of diabetes and includes a continuous glucose monitoring feature.
The recall was initiated because Animas determined that the Hebrew language translation on the pump was incorrect. Additionally, one line of Hebrew text was omitted from the display screen. These errors could lead to potential patient confusion.
Consumers in Israel who possess the affected model numbers should contact Animas Corporation for further instructions. The affected model numbers include various PMPW/OKIT, REV KIT, and VIBEPL configurations ending in 'mg,IL'.
The recalled product
- Product
- Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
- Manufacturer
- Animas Corporation
- Category
- Medical Device — Insulin Pump
- Affected units
- 1,028
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number(s): 11220008 PMPW/OKIT
- VIBE
- BLU
- mg
- IL 11220108 PMPW/OKIT
- BLK
- IL 11220208 PMPW/OKIT
- SIL
- IL 11220408 PMPW/OKIT
- PGL
- IL 11220508 PMPW/OKIT
- LGN
- IL 11251008 REV KIT
- IL 11251108 REV KIT
- IL 11251208 REV KIT
- IL 11251408 REV KIT
- IL 11251508 REV KIT
- IL 11451008 REV KIT
- VIBEPL
- IL 11451108 REV KIT
Distribution
Distribution scope not specified by the agency.
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