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 Initiated
- August 12, 2020
- Terminated
- April 2, 2021
- Recall Number
- Z-3015-2020
- Quantity
- 110 units
- Firm Location
- Portage, MI
Reason for Recall
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
Distribution
US Nationwide distribution including in the states of CA, FL, NY, OH.
Lot / Code Info
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 2020018700137 2020018700138 2020018700139 2020018700140 2020018700141 2020018700142 2020018700143 2020018700144 2020018700145 2020018700146 2020018700147 2020018700148 2020018700149 2020018700150 2020018700151 2020018700152 2020018700153 2020018700154 2020018700155 2020018700156 2020018700157 2020018700158 2020018700159 2020018700160 2020018700167 2020018700169 2020018700206 2020018700209 2020018700210 2020018700211 2020018700212 2020018700213 2020018700214 2020018700239 2020018700240 2020018700241 2020018700242 2020018700243 2020018700244 2020018700245 2020018700246 2020018700247 2020018700248 2020018700250 2020018700251 2020018700252 2020018700253 2020018700254 2020018700255 2020018700256 2020018700257 2020018700258 2020018700259 2020018700260 2020018700261 2020018700262 2020018700263 2020018700264 2020018700265 2020018700266 2020018700267 2020018700268 2020018700281 2020018700282 2020018700283 2020018700284 2020018700285 2020018700286 2020018700287 2020018700288 2020018700289 2020018700290 2020018700291 2020018700292 GTIN Number: 07613327503999
Root Cause
Nonconforming Material/Component
Action Taken
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 productfieldaction@stryker.com. 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).