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Recall Observatory FDA recall evidence

Device product

120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 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.

Z-2627-2018

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-2627-2018

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 B9622, Lot Number 3327623, 3332856, 3338452, 3351761, 3355549, 3371150, 3373269, 3374329, 3384355, 3387646, 3391948, 3401837, 3405445, 3408966, 3423453

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.