Medical DeviceFeb 1, 2017
Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with recall — FDA Z-1084-2017
Outer Packaging is not sterile
Class IIFDA: TerminatedAtrium Medical Corporation
Recall history in this database
Classification mix: Class II: 111, Class I: 2.
Medical DeviceFeb 1, 2017
Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line recall — FDA Z-1083-2017
Outer Packaging is not sterile
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceFeb 1, 2017
Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric recall — FDA Z-1081-2017
Outer Packaging is not sterile
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceFeb 1, 2017
Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors recall — FDA Z-1079-2017
Outer Packaging is not sterile
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceFeb 1, 2017
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain recall — FDA Z-1082-2017
Outer Packaging is not sterile
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceFeb 1, 2017
Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or recall — FDA Z-1088-2017
Outer Packaging is not sterile
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceFeb 1, 2017
Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) recall — FDA Z-1085-2017
Outer Packaging is not sterile
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceFeb 1, 2017
Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain recall — FDA Z-1086-2017
Outer Packaging is not sterile
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceNov 23, 2016
Atrium Medical 16 Fr Trocar catheter recall — FDA Z-0579-2017
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceNov 23, 2016
Atrium Medical 32 Fr Trocar catheter, Sterile recall — FDA Z-0583-2017
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceNov 23, 2016
Atrium Medical 20 Fr Trocar catheter, sterile recall — FDA Z-0580-2017
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceNov 23, 2016
Atrium Medical 8 Fr Trocar catheter, Sterile recall — FDA Z-0576-2017
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceNov 23, 2016
Atrium Medical 10 Fr Trocar catheter, Sterile recall — FDA Z-0577-2017
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceNov 23, 2016
Atrium Medical 28 Fr Trocar catheter, Sterile recall — FDA Z-0582-2017
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceNov 23, 2016
Atrium Medical 12 Fr Trocar catheter, Sterile recall — FDA Z-0578-2017
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceNov 23, 2016
Atrium Medical 24 Fr Trocar catheter, Sterile recall — FDA Z-0581-2017
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Class IIFDA: TerminatedAtrium Medical Corporation
Medical DeviceAug 12, 2015
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236 recall — FDA Z-2346-2015
Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
Class IIFDA: TerminatedAtrium Medical Corporation
Understanding this recall history
This page summarizes recall records in which the official source identifies Atrium Medical Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.