Freudenberg Medical, Llc recalls Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Read the official notice →- Date
- 2022-05-04
- Country
- United States
- Brand
- Freudenberg Medical
- Product
- Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
- Classification
- Class II
- Units
- US distribution: GA, OH Foreign distribution: Netherlands
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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