| Date Initiated by Firm | July 21, 2017 |
|---|
| Create Date | January 27, 2018 |
|---|
| Recall Status1 |
Terminated 3 on March 22, 2018 |
| Recall Number | Z-0419-2018 |
|---|
| Recall Event ID |
78886 |
| 510(K)Number | K101705 |
|---|
| Product Classification |
System, thermal regulating - Product Code DWJ
|
| Product | MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM |
|---|
| Code Information |
LOT #(s): 1640002, 1645003 |
Recalling Firm/
Manufacturer |
Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
|
Manufacturer Reason
for Recall | It was identified that the Mistral-Air Premium blankets may be capable of
conducting electricity during a defibrillation or cardioversion therapy at higher
energy levels (70 Joules or more) when the blanket is applied with the reflective
side toward the patient (upside down). |
|---|
FDA Determined
Cause 2 | Component design/selection |
|---|
| Action | Stryker notified customers of the recall by sending Customer Notification and Business Reply Forms, dated July 21, 2017. |
|---|
| Quantity in Commerce | 11160 |
|---|
| Distribution | U.S. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = DWJ
|
|---|
