FDA Device recall Z-0017-2025

ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

FDA Device
Class II
ongoing
Published 2024-10-30

On 2024-10-30 the FDA classified a Class II recall of ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28 by Smiths Medical Asd, citing certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0017-2025
Classification	Class II
Status	ongoing
Initiated	2024-06-26
Published	2024-10-30
Last updated	2026-09-13 11:57 UTC
Company	Smiths Medical Asd
Distribution	n/a

Product

ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

Reason

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Identifiers

code_info	UDI/DI 30610586044179, Lot Numbers: 4010559AB, 4010560AB, 4010563AB, 4010573AB, 4016496AB, 4010561AB, 4010562AB, 40164… UDI/DI 30610586044179, Lot Numbers: 4010559AB, 4010560AB, 4010563AB, 4010573AB, 4016496AB, 4010561AB, 4010562AB, 4016490AB, 4010570AB, 4010569AB, 4016494AB, 4016497AB, 4010571AB, 4016491AB, 4010572AB, 4010574AB, 4016493AB, 4022630AB, 4025275AB, 4016492AB, 4016495AB, 4022621AB, 4022625AB, 4022628AB, 4006931AB, 4006933AB, 4006930AB, 4006932AB, 4022622AB, 4022623AB, 4022627AB, 4022624AB, 4022626AB, 4022632AB, 4022629AB, 4022631AB, 4025277AB, 4022633AB, 4022634AB, 4025274AB, 4022635AB, 4033938AB, 4033939AB, 4025281AB, 4033937AB, 4025278AB, 4025279AB, 4025280AB, 4033943AB, 4025288AB, 4025282AB, 4025289AB, 4025285AB, 4025286AB, 4025290AB, 4025287AB, 4033934AB, 4033928AB, 4030519AB, 4025291AB, 4025292AB, 4025293AB, 4039970AB, 4039972AB, 4030518AB, 4025295AB, 4039971AB, 4033942AB, 4033927AB, 4033940AB, 4033931AB, 4033930AB, 4033932AB, 4010548AB, 4010551AB, 4033933AB, 4033935AB, 4033936AB, 4039983AB, 4033941AB, 4039973AB, 4039969AB, 4039974AB, 4039987AB, 4039978AB, 4039981AB, 4039975AB, 403997

code_info

UDI/DI 30610586044179, Lot Numbers: 4010559AB, 4010560AB, 4010563AB, 4010573AB, 4016496AB, 4010561AB, 4010562AB, 40164…

UDI/DI 30610586044179, Lot Numbers: 4010559AB, 4010560AB, 4010563AB, 4010573AB, 4016496AB, 4010561AB, 4010562AB, 4016490AB, 4010570AB, 4010569AB, 4016494AB, 4016497AB, 4010571AB, 4016491AB, 4010572AB, 4010574AB, 4016493AB, 4022630AB, 4025275AB, 4016492AB, 4016495AB, 4022621AB, 4022625AB, 4022628AB, 4006931AB, 4006933AB, 4006930AB, 4006932AB, 4022622AB, 4022623AB, 4022627AB, 4022624AB, 4022626AB, 4022632AB, 4022629AB, 4022631AB, 4025277AB, 4022633AB, 4022634AB, 4025274AB, 4022635AB, 4033938AB, 4033939AB, 4025281AB, 4033937AB, 4025278AB, 4025279AB, 4025280AB, 4033943AB, 4025288AB, 4025282AB, 4025289AB, 4025285AB, 4025286AB, 4025290AB, 4025287AB, 4033934AB, 4033928AB, 4030519AB, 4025291AB, 4025292AB, 4025293AB, 4039970AB, 4039972AB, 4030518AB, 4025295AB, 4039971AB, 4033942AB, 4033927AB, 4033940AB, 4033931AB, 4033930AB, 4033932AB, 4010548AB, 4010551AB, 4033933AB, 4033935AB, 4033936AB, 4039983AB, 4033941AB, 4039973AB, 4039969AB, 4039974AB, 4039987AB, 4039978AB, 4039981AB, 4039975AB, 403997

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0017-2025%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.