Recall Z-1258-2016 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ICU Medical, Inc.
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.
| Date | Feb 25, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | A customer notification letter dated 2/25/16 was sent to all customers who purchased the IV Administration Sets with ChemoLock Port to inform them that ICU Medical has identified an issue with a connection in an isolated number of I.V. Infusion administration sets that incorporate the ChemoLock 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. Customers are informed of the actions to be taken. Customers are instructed to return and complete the recall response form to ICU Medical via Fax (801) 2 |
| Quantity | 19,250 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131549 | CHEMOLOCK, CHEMOLOCK PORT Icu Medical, Inc., Jul 26, 2013 |