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
Recall
- Recall Number
- Z-3015-2020
- Event Number
- 86323
- Firm
- Stryker Medical Division of Stryker Corporation
- FEI Number
- 1831750
- Product Code
- IKY
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 12, 2020
- Terminated
- April 2, 2021
- Address
- 3800 E Centre Ave, Portage, MI, 49002-5826
Description
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
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
Stryker issued Medical Device Correction Notice dated 8/12/20, initially in person or via email by a Stryker Sales Representative with the customer notification letter. Letter states reason for recall, health risk, action to take: 1. Locate the units listed on the attached business reply form and remove them from use until they can be corrected. 2. Return the enclosed business reply form to confirm receipt of this notification by fax 269 488 8691 or email [email protected]. 3. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the correction of your IsoAir 2.0 support surface. 4. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 5. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form. Questions: contact Customer Service +1 800 327 0770. Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).
US Nationwide distribution including in the states of CA, FL, NY, OH.
110 units