ICU Medical, Inc.: ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

Agency Publication Date: October 11, 2018

Affected Products

Product: 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341.

2912285

Product: 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 011-CL3511 sterile devices intended for the infusion and withdrawal of fluids.

2860408 2903727 2938260 3048128 3072971

Product: 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal of fluids.

2938262

Product: 110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3300 sterile devices intended for the infusion and withdrawal of fluids.

3114044 3118069 3124607 3128408 3183022

Product: 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of fluids.

2603990 2638178 2648080 2650789 2651575 2707143 2758814 2775922 2807999 2812304 2822505 2935268 2959788 2981443 2996455 3004510 3004872 3014970 3021774 3031244 3036751 3042661 3050748 3062734 3066394 3070408 3090587 3093069 3095818 3099253 3104787 3106886 3113237 3116568 3124603 3128411 3150731 3160102 3168416 3175643 3179949 3184510

Product: 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids.

2775926 2812305 2817810 2822507 2869949 2906006 2935267 2956661 3000036 3021000 3022814 3050749 3093071 3106072 3112028 3113234 3116570 3122924 3124606 3128409 3146957 3154612 3158607 3160103 3172391 3179951 3182579

Product: 30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3528 sterile devices intended for the infusion and withdrawal of fluids.

2770706

Product: 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile devices intended for the infusion and withdrawal of fluids.

3132625 3136286 3158761

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73391

Status: Resolved

Manufacturer: ICU Medical, Inc.

Manufactured In: United States

Units Affected: 8 products (100; 215 units; 50 units; 350 units; 19,250 units; 7,500 units; 50 units; 400 units)

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Sources: FDA iRES · Raw API Response

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