CLASS II ONGOING Device recall · Reported 21 Sep 2022 · FDA Enforcement Report
Appx, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros, Red Cap recalled
ICU Medical is recalling Appx, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros, Red Cap, distributed in 52 states. The recall was initiated on 1 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1723-2022
- FDA event ID
- 90726
- Recalling firm
- ICU Medical, San Clemente, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Aug 2022
- FDA classified
- 9 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 1 Aug 2022 | Recall initiated by company | |
| 9 Sep 2022 | Classified by FDA | +39 days |
| 21 Sep 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
Where it was distributed
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam. O.U.S.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Which lots are affected?
Product Number: CH3771 UDI Code: 0110887709098678172702013050105782919 Lot Numbers: 5782919
Where was it sold?
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam. O.U.S.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 90726| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MicroClave Clear Neutral Connector recalled by ICU Medical | ICU Medical | Device Malfunction | 52 states | |
| CLASS II | 6" Appx, Smallbore Trifuse Ext Set w/3 MicroClave Clear recalled | ICU Medical | Device Malfunction | 52 states | |
| CLASS II | MicroClave Clear Neutral Connector recalled by ICU Medical | ICU Medical | Device Malfunction | 52 states | |
| CLASS II | 8.5" Appx, Bifuse Pressure Infusion recalled by ICU Medical | ICU Medical | Device Malfunction | 52 states | |
| CLASS II | 6.5" Appx, Smallbore Bifuse Ext Set w/2 MicroClave Clear recalled | ICU Medical | Device Malfunction | 52 states |
More recalls from ICU Medical
All 654| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hotline Fluid Warming Set, single use device recalled by ICU Medical | ICU Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump recalled by ICU Medical | ICU Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Plum Duo Infusion Pump recalled by ICU Medical | ICU Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Plum Duo Precision IV Pump recalled by ICU Medical | ICU Medical | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |