8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062946(17)250101(30)50(10)4603254; (01)10887709062946(17)250201(30)50(10)4630684; (01)10887709062946(17)250201(30)50(10)4718516; (01)10887709062946(17)241201(30)50(10)4514832; (01)10887709062946(17)241201(30)50(10)4537159; (01)10887709062946(17)250101(30)50(10)4558447; (01)10887709062946(17)250201(30)50(10)4724820; (01)10887709062946(17)250201(30)50(10)4733554. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers:4603254, 4630684, 4718516, 4514832, 4537159, 4558447, 4724820, 4733554.
- 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, Inc.
- Reason for Recall:
- Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062946(17)250101(30)50(10)4603254; (01)10887709062946(17)250201(30)50(10)4630684; (01)10887709062946(17)250201(30)50(10)4718516; (01)10887709062946(17)241201(30)50(10)4514832; (01)10887709062946(17)241201(30)50(10)4537159; (01)10887709062946(17)250101(30)50(10)4558447; (01)10887709062946(17)250201(30)50(10)4724820; (01)10887709062946(17)250201(30)50(10)4733554. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
Product Codes/Lot Numbers:
Lot Numbers:4603254, 4630684, 4718516, 4514832, 4537159, 4558447, 4724820, 4733554.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0276-2021
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