FDA Device recall Z-1721-2022

6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock

FDA Device
Class II
ongoing
Published 2022-09-21

On 2022-09-21 the FDA classified a Class II recall of 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock 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-1721-2022
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

6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

Reason

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

Identifiers

code_info	Product Number: 011-MC33538 UDI Code: 0110840619072435172701013050105772700 Lot Numbers: 5772700 Product Number: A100… Product Number: 011-MC33538 UDI Code: 0110840619072435172701013050105772700 Lot Numbers: 5772700 Product Number: A1009 UDI Codes: 0110887709051055172612013050105747112 Lot Numbers: 5747112 Product Number: A1129 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 Lot Number 5755485 5772087 Product Number: AC235 UDI Code: 0110887709122069172702013050105782946 Lot Number: 5782946 Product Number: MB4V01 UDI Code: 0110887709079578172701013050105797658 Lot Number: 5797658 Product Number: MC330073 UDI Codes: 0110887709076690172612013050105724537 Lot Numbers: 5724537 Product Number: MC330255 UDI Codes: 0110887709081670172611013050105712884 Lot Numbers: 5712884 Product Number: MC3302R UDI Codes: 0110887709037271172612013050105745628 Lot Numbers: 5745628 Product Number: MC330362 UDI Code: 0110887709085319172701013050105772361 Lot Number: 5772361 Product Number: MC330417 UDI Code: 0110887709087504172701013050105782954 0110887709087504172702013050105816

code_info

Product Number: 011-MC33538 UDI Code: 0110840619072435172701013050105772700 Lot Numbers: 5772700 Product Number: A100…

Product Number: 011-MC33538 UDI Code: 0110840619072435172701013050105772700 Lot Numbers: 5772700 Product Number: A1009 UDI Codes: 0110887709051055172612013050105747112 Lot Numbers: 5747112 Product Number: A1129 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 Lot Number 5755485 5772087 Product Number: AC235 UDI Code: 0110887709122069172702013050105782946 Lot Number: 5782946 Product Number: MB4V01 UDI Code: 0110887709079578172701013050105797658 Lot Number: 5797658 Product Number: MC330073 UDI Codes: 0110887709076690172612013050105724537 Lot Numbers: 5724537 Product Number: MC330255 UDI Codes: 0110887709081670172611013050105712884 Lot Numbers: 5712884 Product Number: MC3302R UDI Codes: 0110887709037271172612013050105745628 Lot Numbers: 5745628 Product Number: MC330362 UDI Code: 0110887709085319172701013050105772361 Lot Number: 5772361 Product Number: MC330417 UDI Code: 0110887709087504172701013050105782954 0110887709087504172702013050105816

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-1721-2022%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.