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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.