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Recall Observatory FDA recall evidence

Device product

30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10; Spinning Spiros Closed Male Luer, Red Cap, REF: CH2000S-C; Spiros, Closed Male Luer w/Red Cap, 10 Units, RES: CH2000SC-10; Spiros, Closed Male Luer w/Red Cap, 5 Units, REF: CH2000SC-5; Spinning Spiros Closed Male Luer, Purple Cap, REF: CH2000S-PC; Conector macho cerrado Spinning Spiros, tapon purpura, REF: 034-CH2000S-PC; Spiros, Purple Cap, Drop-In Priming Cap, REF: CH2000S-PCP; Spinning Spiros Closed Male Luer w/Red Cap, REF: CH3515; Spinning Spiros Closed Male Luer, REF: Z7072

Z-0702-2021

August 31, 2020

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 86426
Status
Ongoing
Classification
Class II
Quantity
1856578
Official record key
device-enforcement:Z-0702-2021

Official wording

Reason: Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Code information: Lots: 4749745, 4764622, 4790769, 4806298, 4865663, 4712177, 4749754, 4757981, 4764633, 4793559, 4903194, 4726692, 4756786, 4800185, 4895432, 4726695, 4749730, 4757614, 4761878, 4784740, 4794303, 4895435, 4713514, 4713516, 4749750, 4749755, 4750947, 4750950, 4750952, 4757618, 4763178, 4806832, 4806838, 4849195, 4858381, 4895446, 4711932, 4726709, 4756789, 4761899, 4783763, 4858387, 4962299, 4726711, 4749767, 4774705, 4784757, 4795443, 4857778, 4727446, 4749771, 4711937, 4727450, 4882569, 4741999, 4757713, 4793544, 4908662, 4749745, 4764622, 4790769, 4865663, 4901210, 4749754, 4764633, 4603678, 4726692, 4756786, 4800185, 4895432, 4713516, 4749733, 4749750, 4749755, 4750947, 4750952, 4763174, 4763178, 4774701, 4774702, 4806838, 4849192, 4849195, 4857774, 4858382, 4895442, 4895446, 4896004, 4902104, 4726709, 4761899, 4727446, 4749771, 4774000, 4849201, 4877398, 4877399

Distribution pattern: Worldwide distribution - U.S. Nationwide distribution including in the states of FL, MD, LA, PA, IN, TX, NY, MO, VA, OH, GA, NC, IL, CA, AZ, AK, NE, DE, WI, CO, UT, ND, MS, MA, MN, WA, SC, OR, KS, MI, NH, NJ, KY, TN, ID, AR, CT, OK, AL, SD, ME, IA, VT, WY, DC, NV, RI, MT, NM, HI, WV and the countries of Italy, Belgium, United Kingdom, Canada, Germany, Argentina, Australia, Poland, Greece, Switzerland, Israel, France, Finland, Spain, Malaysia, Taiwan, Ireland, Luxembourg, Hong Kong , Brazil, Netherlands, Austria, Sweden, Turkey, Singapore, Slovakia, Croatia, South Africa, Romania, Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.