CLASS IIDevice recall · Reported 15 Aug 2018 · FDA Enforcement Report
117" Y-Type Blood Set w/170 Micron Filter, Hand Pump recalled
ICU Medical is recalling 117" Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way, 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
Lot, batch or date codesItem Number Z3843, Lot Number 70-973-SJ, 71-474-Y1, 73-006-JW, 73-641-HE, 74-340-JW
Quantity recalled160,016 units total
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
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
117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, 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.
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 Z3843, Lot Number 70-973-SJ, 71-474-Y1, 73-006-JW, 73-641-HE, 74-340-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.