42 IN — Class II medical device recall Z-0699-2021
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-0699-2021 |
|---|---|
| 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 | 19,850 |
| Reason classes | packaging |
| Lot numbers | 4719565, 4719787, 4724813, 4733498, 4734320, 4734335, 4736129, 4737148, 4741238, 4741243, 4749863, 4749867, 4749880, 4749900, 4751063, 4751101, 4751908, 4756873, 4757706, 4763286, 4763289, 4764061, 4764065, 4764635, 4774081, 4774117, 4775529, 4777159, 4787215, 4790766, 4793547, 4793550, 4799805, 4809085, 4849350, 4849358, 4849376, 4849389, 4849391, 4850390 and 12 more |
| Model numbers | 20131-01, B4194, CH3330-C, CH3353, CH3367, CH3379, CH3381, CH3386, CH3401, CH3405, CH3453, CH3485, CH3517, CH3523, CH3533, CH3538, CH3556, CH3603, Z7093, Z7182 |
Product
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Clamps, Spiros, REF: CH3367; 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, Spiros, 2 Clamps, REF: CH3379; 16" (41 cm) Appx 4.4 ml, Ext Set w/MicroClave, 0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3381; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Drop-in Red Cap, 2 Hanger, REF: CH3386; 40" (102 cm) Appx 7.3 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: CH3401; 60" (152 cm) Appx 0.62 ml, Smallbore Ext Set w/MicroClave, Clamp, Spiros w/Red Cap, REF: CH3405; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, REF: CH3453; 73" (185 cm) Appx 2.1 ml, Smallbore Ext Set w/MicroClave Clear, Spiros, Clamp, REF: CH3485; 42" (107 cm) Appx 4.8 ml, 15 Drop Admin Set w/Spiros w/Red Cap, Bag Hanger, Drop-In Priming Cap, REF: CH3517; 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/MicroClave Clear, 2 Spiros, 3 Clamps, Priming Cap, REF: CH3523; 74" (188 cm) Smallbore Ext Set w/MicroClave, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3533; 74 IN (188 cm) Appx 0.92 ml, Smallbore Set, MicroClave, 1.2 Micron Fil, Spiros, Red Cap, REF: CH3538; 18" (46 cm) Appx 5.1 ml, Ext Set w/0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3556; 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; 4-Way Clave Stopcock w/2 Spiros, REF: B4194; Spiros, Closed Male Connector w/Red Cap (10 Units), REF: Z7093; 47" (119 cm) 150 ml Burette Set w/MicroClave, 20 Drop In-Line Drip Chamber w/Ball Shut Off, Spiros, REF: Z7182
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.