FDAFDA · Food and drugs·Recall number Z-1259-2016
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.
Published April 6, 2016 · Recall initiated: February 25, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- US: NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO Non-US: DE, AE, AT, PL, HU, SE, IL, JP, JO, SA,
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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