40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item Number011-AM6126. a. Lot Number 3409000, UDI Number (01) 1 0840619 09534 2 (17) 220201 (30) 50 (10) 3409000, Expiration Date 02/01/2022; b. Lot Number 3446970, UDI Number (01) 1 0840619 09534 2 (17) 220201 (30) 50 (10)3446970, Expiration Date 05/01/2022
- 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:
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Product Codes/Lot Numbers:
Item Number011-AM6126. a. Lot Number 3409000, UDI Number (01) 1 0840619 09534 2 (17) 220201 (30) 50 (10) 3409000, Expiration Date 02/01/2022; b. Lot Number 3446970, UDI Number (01) 1 0840619 09534 2 (17) 220201 (30) 50 (10)3446970, Expiration Date 05/01/2022
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-2808-2018
Related Recalls
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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.