TELEFLEX MEDICAL INC 2022-02-23 Health critical FDA
Health · FDA · Recall #FDA-Z-0625-2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W… Recall
Issued February 23, 2022 · TELEFLEX MEDICAL INC
In February 2022, TELEFLEX MEDICAL INC recalled the Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The firm received reports indicating PTD tip separation during use.
What you should do
- 1 Stop using Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact TELEFLEX MEDICAL INC 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
- TELEFLEX MEDICAL INC
- Category
- Health
- Recall date
- February 23, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- Recall number
- FDA-Z-0625-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- TELEFLEX MEDICAL INC has 1 recall in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.