REF: Z2560 — Class II medical device recall Z-1916-2020

Terminated recall by ICU Medical, Inc., reported 2020-05-13, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL d

Recall number	`Z-1916-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	ICU Medical, Inc., San Clemente, CA, United States
Recall initiated	2019-10-04
Classified	2020-05-06
Reported by FDA	2020-05-13
Terminated	2021-12-28
Distributed	AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY
Countries outside the US	CA
Quantity	650 units
UPC / GTIN / UDI-DI	`00887709026889`
Lot numbers	`4172061`, `4173149`
Model numbers	`Z2560`

Product

REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889

Reason for recall

There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1916-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.