CLASS II Device recall · Reported 15 Aug 2018 · FDA Enforcement Report
126" Y-Type Blood Set w/170 Micron Filter, Hand Pump recalled
ICU Medical is recalling 126" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, distributed nationwide in the US. The recall was initiated on 31 Jul 2017 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-2654-2018
- FDA event ID
- 80427
- Recalling firm
- ICU Medical, San Clemente, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jul 2017
- FDA classified
- 7 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Syringes & Needles
Timeline
| 31 Jul 2017 | Recall initiated by company | |
| 7 Aug 2018 | Classified by FDA | +372 days |
| 15 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
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
126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Where it was distributed
Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
Nationwide AlabamaArkansasCaliforniaConnecticutDelawareFloridaIowaIllinoisIndianaKansasMassachusettsMarylandMaineMichiganMissouriNorth CarolinaNew JerseyNew YorkOhioOregon
Questions about this recall
Why was it recalled?
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Which lots are affected?
Item Number Z3521, Lot Number 74-350-JW
Where was it sold?
Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
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
52 other products · FDA event 80427This product is part of a recall event; the main page for the event is 140" Y-Type Blood Set w/170 Micron Filter, Hand Pump recalled.
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 Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |