Reported Dec 30, 2020 · Ongoing
76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger,…
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
9 of 9 products
| Model / number | Product as published |
|---|---|
011-CH3261 | 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP |
011-CH3568 | Oncology Kit, 5 Gang Stopcock w/5 ChemoClave, Spiros w/Red Cap; 10cm Smallbore Bifuse Ext w/2 ChemoClave, Red Ring, BCV; 297cm Ext w/ChemoClave |
011-CH3600 | Oncology Kit, 5 Gang Stopcock w/5 ChemoClave, Spiros w/Red Cap; 10cm Smallbore Bifuse Ext, w/2 ChemoClave, Red Ring, BCV; 597 cm Ext w/ChemoClave |
011-CH3601 | Kit, 2 5 Gang Stopcocks w/5 MicroClave Clear, Spiros; 2 Smallbore Bifuse Ext Sets, 2 MicroClave Clear, Red Ring, Check Valve, RMLL; 2 Ext Sets, MicroClave Clear Clipped Together, RMLL |
011-CH3610 | Admin Set w/Clave, Spiros |
011-CH3772 | Admin Set w/Clave, Spiros |
011-CH3773 | Admin Set w/Clave, Spiros |
011-CH3967 | 76" (193 cm) 50 ml, Diluent Set for Channel 2 w/20 Drop Drip Chamber, Spiros, Drop-In Red Cap |
011-CH4011 | — |
- Lot codes and dates
- Lots
478439047844044865931486500645902834774210486595247112644605516472310348820164806569
- Lots
- Amount recalled
- 4790
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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