Z-1258-2016Class II

30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red...

Name: Z-1258-2016 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red...
Creator: ICU Medical, Inc.
Published: 2016-02-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-02-25 / Terminated

FDA source

ICU Medical, Inc. began a recall of 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... on 2016-02-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1258-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-25
Posted: 2018-10-11
Terminated: 2016-08-26
Recalling firm: Abbott Medical
Product: 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.
Product code: ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
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.
FDA 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: [email protected]. 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 [email protected].
Quantity in commerce: 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,
Product codes and lots: 2603990 2638178 2648080 2650789 2651575 2707143 2758814 2775922 2807999 2812304 2822505 2935268 2959788 2981443 2996455 3004510 3004872 3014970 3021774 3031244 3036751 3042661 3050748 3062734 3066394 3070408 3090587 3093069 3095818 3099253 3104787 3106886 3113237 3116568 3124603 3128411 3150731 3160102 3168416 3175643 3179949 3184510

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1258-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1254-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25
Z-1255-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25
Z-1256-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25
Z-1257-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25
Z-1258-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25
Z-1259-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25
Z-1260-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25
Z-1261-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25

Product code ONB

K131549Class IIChemolock, Chemolock PortIcu Medical, Inc. / cleared 2013-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)