FDA Device recall Z-3015-2020
Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the pati…
- FDA Device
- Class II
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the pati… by Stryker Medical Division, citing connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients expe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3015-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-12 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Medical Division |
| Distribution | US |
Product
Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100
Reason
Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing cardiac arrest and needing CPR
Identifiers
| code_info | Serial Numbers: 2020018700101 2020018700102 2020018700103 2020018700104…Serial Numbers: 2020018700101 2020018700102 2020018700103 2020018700104 2020018700105 2020018700106 2020018700107 2020018700108 2020018700109 2020018700110 2020018700111 2020018700112 2020018700113 2020018700114 2020018700115 2020018700116 2020018700117 2020018700118 2020018700119 2020018700120 2020018700121 2020018700122 2020018700123 2020018700124 2020018700125 2020018700126 2020018700127 2020018700128 2020018700129 2020018700130 2020018700131 2020018700132 2020018700133 2020018700134 2020018700135 2020018700136 20200187001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3015-2020%22
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