Stradis Medical, LLC dba Stradis Healthcare 2022-12-21 Health serious FDA
Health · FDA · Recall #FDA-Z-0546-2023
STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1, Recall
Issued December 21, 2022 · Stradis Medical, LLC dba Stradis Healthcare
In December 2022, Stradis Medical, LLC dba Stradis Healthcare recalled the STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
What you should do
- 1 Stop using STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1, right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Stradis Medical, LLC dba Stradis Healthcare 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
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Health
- Recall date
- December 21, 2022
- Units affected
- Not reported
- Sold at
- US nationwide distribution, and Canada.
- Recall number
- FDA-Z-0546-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Stradis Medical, LLC dba Stradis Healthcare has 11 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.