42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Clamps, Spiros, REF: CH3367; 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, Spiros, 2 Clamps, REF: CH3379; 16" (41 cm) Appx 4.4 ml, Ext Set w/MicroClave, 0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3381; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Drop-in Red Cap, 2 Hanger, REF: CH3386; 40" (102 cm) Appx 7.3 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: CH3401; 60" (152 cm) Appx 0.62 ml, Smallbore Ext Set w/MicroClave, Clamp, Spiros w/Red Cap, REF: CH3405; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, REF: CH3453; 73" (185 cm) Appx 2.1 ml, Smallbore Ext Set w/MicroClave Clear, Spiros, Clamp, REF: CH3485; 42" (107 cm) Appx 4.8 ml, 15 Drop Admin Set w/Spiros w/Red Cap, Bag Hanger, Drop-In Priming Cap, REF: CH3517; 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/MicroClave Clear, 2 Spiros, 3 Clamps, Priming Cap, REF: CH3523; 74" (188 cm) Smallbore Ext Set w/MicroClave, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3533; 74 IN (188 cm) Appx 0.92 ml, Smallbore Set, MicroClave, 1.2 Micron Fil, Spiros, Red Cap, REF: CH3538; 18" (46 cm) Appx 5.1 ml, Ext Set w/0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3556; 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; 4-Way Clave Stopcock w/2 Spiros, REF: B4194; Spiros, Closed Male Connector w/Red Cap (10 Units), REF: Z7093; 47" (119 cm) 150 ml Burette Set w/MicroClave, 20 Drop In-Line Drip Chamber w/Ball Shut Off, Spiros, REF: Z7182

Class I - Dangerous

🏥 Medical Devices Recalled: August 31, 2020 ICU Medical Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
Lot: 4764635, 4887770, 4787215, 4877053, 4737148, 4850390, 4749863, 4849350, 4867377, 4741238, 4763286, 4774081, 4809085, 4877072, 4908343, 4719787, 4734320, 4741243, 4749867, 4854763, 4895575, 4849358, 4751063, 4763289, 4775529, 4724813, 4749880, 4854774, 4734335, 4757706, 4849376, 4764061, 4793547, 4749900, 4756873, 4777159, 4799805, 4902253, 4751908, 4793550, 4849389, 4896178, 4733498, 4764065, 4849391, 4719565, 4751101, 4790766, 4774117, 4736129, 4895706, 4858370
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:: Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Clamps, Spiros, REF: CH3367; 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, Spiros, 2 Clamps, REF: CH3379; 16" (41 cm) Appx 4.4 ml, Ext Set w/MicroClave, 0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3381; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Drop-in Red Cap, 2 Hanger, REF: CH3386; 40" (102 cm) Appx 7.3 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: CH3401; 60" (152 cm) Appx 0.62 ml, Smallbore Ext Set w/MicroClave, Clamp, Spiros w/Red Cap, REF: CH3405; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, REF: CH3453; 73" (185 cm) Appx 2.1 ml, Smallbore Ext Set w/MicroClave Clear, Spiros, Clamp, REF: CH3485; 42" (107 cm) Appx 4.8 ml, 15 Drop Admin Set w/Spiros w/Red Cap, Bag Hanger, Drop-In Priming Cap, REF: CH3517; 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/MicroClave Clear, 2 Spiros, 3 Clamps, Priming Cap, REF: CH3523; 74" (188 cm) Smallbore Ext Set w/MicroClave, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3533; 74 IN (188 cm) Appx 0.92 ml, Smallbore Set, MicroClave, 1.2 Micron Fil, Spiros, Red Cap, REF: CH3538; 18" (46 cm) Appx 5.1 ml, Ext Set w/0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3556; 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; 4-Way Clave Stopcock w/2 Spiros, REF: B4194; Spiros, Closed Male Connector w/Red Cap (10 Units), REF: Z7093; 47" (119 cm) 150 ml Burette Set w/MicroClave, 20 Drop In-Line Drip Chamber w/Ball Shut Off, Spiros, REF: Z7182

Product Codes/Lot Numbers:

Lot: 4764635, 4887770, 4787215, 4877053, 4737148, 4850390, 4749863, 4849350, 4867377, 4741238, 4763286, 4774081, 4809085, 4877072, 4908343, 4719787, 4734320, 4741243, 4749867, 4854763, 4895575, 4849358, 4751063, 4763289, 4775529, 4724813, 4749880, 4854774, 4734335, 4757706, 4849376, 4764061, 4793547, 4749900, 4756873, 4777159, 4799805, 4902253, 4751908, 4793550, 4849389, 4896178, 4733498, 4764065, 4849391, 4719565, 4751101, 4790766, 4774117, 4736129, 4895706, 4858370