216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item Number 011-AM3010. Lot Number 3424312, UDI Number (01) 1 0840619 09487 1 (17) 220301 (30) 50 (10) 3424312, Expiration Date 03/01/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ICU Medical de Mexico, S.A. de C.V.
- Reason for Recall:
- ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
Product Codes/Lot Numbers:
Item Number 011-AM3010. Lot Number 3424312, UDI Number (01) 1 0840619 09487 1 (17) 220301 (30) 50 (10) 3424312, Expiration Date 03/01/2022
Distribution:
Distributed in: US, AZ, MA, NC, OH, TX, VA, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2801-2018
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ICU Medical de Mexico, S.A. de C.V.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.