RecallRadar

FDA Device recall Z-0577-2017

Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest c…

On 2016-11-23 the FDA classified a Class II recall of Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest c… by Atrium Medical, citing trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0577-2017
ClassificationClass II
Statusterminated
Initiated2016-10-26
Published2016-11-23
Last updated2026-09-13 11:54 UTC
CompanyAtrium Medical
DistributionPR

Product

Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

Reason

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Identifiers

code_infoAll lot codes

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-0577-2017%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.