FDA Device recall Z-1724-2022

6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer

FDA Device
Class II
ongoing
Published 2022-09-21

On 2022-09-21 the FDA classified a Class II recall of 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer by Icu Medical, citing due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1724-2022
Classification	Class II
Status	ongoing
Initiated	2022-08-01
Published	2022-09-21
Last updated	2026-09-13 11:56 UTC
Company	Icu Medical
Distribution	AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY

Product

6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;

Reason

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

Identifiers

code_info	Product Numbers / Lot Numbers / UDI Codes: IR-1SF 5727531 01549878920700181724120130100105727531 IR-1S 5728008 01549878… Product Numbers / Lot Numbers / UDI Codes: IR-1SF 5727531 01549878920700181724120130100105727531 IR-1S 5728008 01549878920698901724120130100105728008 IR-1SF 5737373 01549878920700181724120130100105737373 IR-1S 5738091 01549878920698901724120130100105738091 IR-1S 5755100 01549878920698901724120130100105755100 P039 5787453 0110840619063112172501013050105787453 MC33769 5664461 0110887709066844172610013050105664461 K7059-001 5692316 0110887709036977172611013050105692316 011-MC100G 5693573 01108406190790141726110130100105693573 LAT-MC100 5714006 01108877090962851726110130100105714006 LAT-MC330021 5714014 0110887709122144172611013050105714014 MC100-DC 5724498 0110887709037165172612013050105724498 MC33636 5725526 0110887709058108172612013050105725526 MC33691 5725559 0110887709064314172612013050105725559 011-MC100RR 5726283 01108406190539771726120130100105726283 011-AM3120 5726777 0110887709098876172612013025105726777 066-MC100 5735598 01108406190842231726120130100105735598 039-MC330487 573633

code_info

Product Numbers / Lot Numbers / UDI Codes: IR-1SF 5727531 01549878920700181724120130100105727531 IR-1S 5728008 01549878…

Product Numbers / Lot Numbers / UDI Codes: IR-1SF 5727531 01549878920700181724120130100105727531 IR-1S 5728008 01549878920698901724120130100105728008 IR-1SF 5737373 01549878920700181724120130100105737373 IR-1S 5738091 01549878920698901724120130100105738091 IR-1S 5755100 01549878920698901724120130100105755100 P039 5787453 0110840619063112172501013050105787453 MC33769 5664461 0110887709066844172610013050105664461 K7059-001 5692316 0110887709036977172611013050105692316 011-MC100G 5693573 01108406190790141726110130100105693573 LAT-MC100 5714006 01108877090962851726110130100105714006 LAT-MC330021 5714014 0110887709122144172611013050105714014 MC100-DC 5724498 0110887709037165172612013050105724498 MC33636 5725526 0110887709058108172612013050105725526 MC33691 5725559 0110887709064314172612013050105725559 011-MC100RR 5726283 01108406190539771726120130100105726283 011-AM3120 5726777 0110887709098876172612013025105726777 066-MC100 5735598 01108406190842231726120130100105735598 039-MC330487 573633

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1724-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.