FDA Device recall Z-0355-2017

Infusion Set, Comfort, 23" Hosp 10

FDA Device
Class II
terminated
Published 2016-11-09

On 2016-11-09 the FDA classified a Class II recall of Infusion Set, Comfort, 23" Hosp 10 by Unomedical As, citing tubing detachment.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0355-2017
Classification	Class II
Status	terminated
Initiated	2014-11-07
Published	2016-11-09
Last updated	2026-09-13 11:54 UTC
Company	Unomedical As
Distribution	CA, IN, PA

Product

Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

Reason

Tubing detachment

Identifiers

code_info	5021247, 5021251, 5021253, 5029813, 5031819, 5031820, 5031821, 5031822, 5031823, 5032577, 5032578, 5033752, 5033753, 50… 5021247, 5021251, 5021253, 5029813, 5031819, 5031820, 5031821, 5031822, 5031823, 5032577, 5032578, 5033752, 5033753, 5033754, 5033755, 5034062, 5034063, 5034064, 5034199, 5034200, 5035085, 5035086, 5035098, 5035099, 5035100, 5037024, 5037025, 5038106, 5038107, 5038108, 5038109, 5038110, 5040382, 5040939, 5040940, 5040941, 5040942, 5040943, 5040944, 5040945, 5040946, 5041053, 5041054, 5041055, 5041056, 5041057, 5043820, 5044874, 5044875, 5044876, 5044877, 5044878, 5044879, 5044880, 5044881, 5044882, 5047110, 5047111, 5047112, 5047113, 5047115, 5047116, 5047117, 5047118, 5047119, 5047121, 5051915, 5053663, 5053664, 5053665, 5053666, 5053667, 5053668, 5053669, 5053670, 5054453, 5054455, 5054456, 5054457, 5054458, 5054459, 5054460, 5054467, 5056817, 5056855, 5056856, 5056857, 5058622, 5058632, 5058636, 5058638, 5058639, 5058640, 5058641, 5058642, 5058735, 5060034, 5060036, 5060037, 5060038, 5060042, 5062768, 5062779, 5062781, 5062782, 5062783, 5062796, 5062814, 5062815, 5065701, 5066393, 5

code_info

5021247, 5021251, 5021253, 5029813, 5031819, 5031820, 5031821, 5031822, 5031823, 5032577, 5032578, 5033752, 5033753, 50…

5021247, 5021251, 5021253, 5029813, 5031819, 5031820, 5031821, 5031822, 5031823, 5032577, 5032578, 5033752, 5033753, 5033754, 5033755, 5034062, 5034063, 5034064, 5034199, 5034200, 5035085, 5035086, 5035098, 5035099, 5035100, 5037024, 5037025, 5038106, 5038107, 5038108, 5038109, 5038110, 5040382, 5040939, 5040940, 5040941, 5040942, 5040943, 5040944, 5040945, 5040946, 5041053, 5041054, 5041055, 5041056, 5041057, 5043820, 5044874, 5044875, 5044876, 5044877, 5044878, 5044879, 5044880, 5044881, 5044882, 5047110, 5047111, 5047112, 5047113, 5047115, 5047116, 5047117, 5047118, 5047119, 5047121, 5051915, 5053663, 5053664, 5053665, 5053666, 5053667, 5053668, 5053669, 5053670, 5054453, 5054455, 5054456, 5054457, 5054458, 5054459, 5054460, 5054467, 5056817, 5056855, 5056856, 5056857, 5058622, 5058632, 5058636, 5058638, 5058639, 5058640, 5058641, 5058642, 5058735, 5060034, 5060036, 5060037, 5060038, 5060042, 5062768, 5062779, 5062781, 5062782, 5062783, 5062796, 5062814, 5062815, 5065701, 5066393, 5

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0355-2017%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.