Freudenberg Medical, Llc 2022-05-04 Health serious FDA
Health · FDA · Recall #FDA-Z-1016-2022
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) Recall
Issued May 4, 2022 · Freudenberg Medical, Llc
In May 2022, Freudenberg Medical, Llc recalled the Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US), a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
What you should do
- 1 Stop using Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Freudenberg Medical, Llc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Freudenberg Medical, Llc
- Category
- Health
- Recall date
- May 4, 2022
- Units affected
- Not reported
- Sold at
- US distribution: GA, OH Foreign distribution: Netherlands
- Recall number
- FDA-Z-1016-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Freudenberg Medical, Llc has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.