Recall Z-1260-2016— ICU Medical, Inc.

Name: FDA recall Z-1260-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-25

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2016-02-25, terminated 2016-08-26. It names one FDA 510(k) clearance: K131549. 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.. Reason: 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..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-25
Terminated: 2016-08-26
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131549 — CHEMOLOCK, CHEMOLOCK PORTIcu Medical, Inc.·cleared 2013-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.