Abiomed, Inc. 2024-01-17 Health serious FDA
Health · FDA · Recall #FDA-Z-0653-2024
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are… Recall
Issued January 17, 2024 · Abiomed, Inc.
In January 2024, Abiomed, Inc. recalled the Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
What you should do
- 1 Stop using Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abiomed, 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
- Abiomed, Inc.
- Category
- Health
- Recall date
- January 17, 2024
- Units affected
- Not reported
- Sold at
- Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK
- Recall number
- FDA-Z-0653-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Abiomed, Inc. has 9 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.