Z-0702-2021 Class II Ongoing
Recalled by ICU Medical, Inc.
— San Clemente, CA
FDA device recall Z-0702-2021 was initiated by ICU Medical, Inc. on August 31, 2020 and is designated Class II. Reason for recall: 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 me… The recall status is ongoing. Affected quantity: 1856578.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- August 31, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1856578
Product Description
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
Reason for Recall
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.
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.
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