FDA Device recall Z-2549-2015

SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…

FDA Device
Class II
terminated
Published 2015-09-09

On 2015-09-09 the FDA classified a Class II recall of SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat… by Customed, citing recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2549-2015
Classification	Class II
Status	terminated
Initiated	2015-07-10
Published	2015-09-09
Last updated	2026-09-13 11:53 UTC
Company	Customed
Distribution	PR

Product

SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Reason

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Identifiers

code_info	Catalog number: 900010 Lots: 141015851 exp. 10/31/2015 150116710 exp.1/31/2016 150117001 exp.2/28/2016 150317560 e… Catalog number: 900010 Lots: 141015851 exp. 10/31/2015 150116710 exp.1/31/2016 150117001 exp.2/28/2016 150317560 exp.3/31/2016 150317560 exp.3/31/2016 150418252 exp.5/31/2016 150418252 exp.5/31/2016 150518605 exp.5/31/2016 150518605 exp.5/31/2016

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2549-2015%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.