FDAFDA · Food and drugs·Recall number Z-1260-2016
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.
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
- 2770706
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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