FDA (Devices) recall action 75347

Atrium Medical Corporation recalled 8 products on 2016-11-23

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2016-11-23
Critical: 0
Units: —

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–8 of 8

ModerateFDA (Devices)··2016-11-23
Atrium Medical Recalls Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 20 Fr Trocar catheters because the packaging labels show more holes than the product actually contains.
Product
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Distribution
1 state
ModerateFDA (Devices)··2016-11-23
Atrium Medical Recalls 8 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 8 Fr Trocar catheters because the packaging label displays an icon with more holes than the actual product contains.
Product
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Distribution
1 state
ModerateFDA (Devices)··2016-11-23
Atrium Medical 16 Fr Trocar Catheter Labeling Error Recall
Atrium Medical is recalling 16 Fr Trocar Catheters because the packaging labels show more eyelets than the product actually contains.
Product
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Distribution
1 state
ModerateFDA (Devices)··2016-11-23
Atrium Medical Recalls 32 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 32 Fr Trocar catheters because the packaging label depicts more eyelets than the product actually contains.
Product
Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Distribution
1 state
ModerateFDA (Devices)··2016-11-23
Atrium Medical Recalls Trocar Catheters Due to Inaccurate Labeling
Atrium Medical is recalling 10 Fr Trocar catheters because the packaging label displays more holes than the product actually contains.
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.
Category
Distribution
1 state
ModerateFDA (Devices)··2016-11-23
Atrium Medical Recalls 28 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 28 Fr Trocar catheters because the packaging label incorrectly depicts more holes than the product actually contains.
Product
Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Distribution
1 state
ModerateFDA (Devices)··2016-11-23
Atrium Medical Recalls 12 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 12 Fr Trocar catheters because the packaging labels show more holes than the product actually contains.
Product
Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Distribution
1 state
ModerateFDA (Devices)··2016-11-23
Atrium Medical 24 Fr Trocar Catheter Recall for Labeling Error
Atrium Medical is recalling 24 Fr Trocar Catheters because the packaging label incorrectly depicts more holes than the product actually contains.
Product
Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Category
Distribution
1 state