Abiomed, Inc. recalls Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally…
Read the official notice →- Date
- 2023-07-19
- Country
- United States
- Brand
- Abiomed
- Product
- Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
- Classification
- Class II
- Units
- US Nationwide distribution in the states of MN, NJ, TN.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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