30" — Class II medical device recall Z-0702-2021
Ongoing recall by ICU Medical, Inc., reported 2020-12-30, distributed nationwide. Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may pote
| Recall number | Z-0702-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2020-08-31 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, DE, ES, FI, FR, GB, GR, HK, HR, IE, IL, IT, LU, MY, NL, PL, RO, SE, SG, SK, TH, TR, TW, ZA |
| Quantity | 1,856,578 |
| Reason classes | packaging |
| Lot numbers | 4603678, 4711932, 4711937, 4712177, 4713514, 4713516, 4726692, 4726695, 4726709, 4726711, 4727446, 4727450, 4741999, 4749730, 4749733, 4749745, 4749750, 4749754, 4749755, 4749767, 4749771, 4750947, 4750950, 4750952, 4756786, 4756789, 4757614, 4757618, 4757713, 4757981, 4761878, 4761899, 4763174, 4763178, 4764622, 4764633, 4774000, 4774701, 4774702, 4774705 and 34 more |
| Model numbers | 034-CH2000S-PC, 20124-01, 20130-01, CH2000S, CH2000S-10, CH2000S-C, CH2000S-PC, CH2000S-PCP, CH2000SC-5, CH3515, Z7072 |
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
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.