Skip to content
Recall Observatory FDA recall evidence

Device product

139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pierced Port, Luer Lock, 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.

Z-2651-2018

July 31, 2017

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 80427
Status
Terminated
Classification
Class II
Quantity
160,016 units total
Official record key
device-enforcement:Z-2651-2018

Official wording

Reason: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Code information: Item Number Z3267, Lot Number 71-008-HE, 71-530-Y1, 71-732-Y1, 72-621-HE, 72-929-HE, 73-008-JW, 73-186-HE, 74-459-JW, 74-740-JW, 75-174-JW, 75-637-JW

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Field note

Send feedback

We'll only use this to respond to your feedback.