FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: 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.
- Recall number
- Z-1254-2016
- Recalling firm
- ICU Medical, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-02-25
- Posted
- not on file
- Terminated
- 2016-08-26
- 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) 264-1755 or by email: recall@icumed.com. Customers with questions or require assistance relating to the recall are instructed to contact Customer Service Monday through Friday between the hours of 8:30AM-4:00PM Pacific Time, (866) 829-9025 and select option 8, or email at customerservice@icumed.com.
- Quantity
- 100
- 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,
- Lot, serial or model codes
- 2912285
- 510(k) numbers
- ["K131549"]
- PMA numbers
- not on file
- Product code
- ONB
- Firm FEI
- 2025816
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28