| Date Initiated by Firm | September 16, 2019 |
|---|
| Create Date | October 30, 2019 |
|---|
| Recall Status1 |
Terminated 3 on December 16, 2020 |
| Recall Number | Z-0248-2020 |
|---|
| Recall Event ID |
83850 |
| 510(K)Number | K083163 |
|---|
| Product Classification |
Generator, oxygen, portable - Product Code CAW
|
| Product | SAROS Oxygen System Model 3000 |
|---|
| Code Information |
Serial Numbers: CBB0817510005, CBB0817510003, CBB0817510004, CBB0817480515, CBB0817460330, CBB0818281053, CBB0817510001, CBB0817510002, CBB0818330784, CBB0818281052 |
Recalling Firm/
Manufacturer |
Caire, Inc.
2200 Airport Industrial Dr Ste 500
Ball Ground GA 30107-4686
|
| For Additional Information Contact | Earl Lawson
770-721-7727 |
|---|
Manufacturer Reason
for Recall | There is an electronics control issue that causes the unit to not power on with battery power only. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| Action | The firm initiated the recall by email on 09/16/2019. The firm explained the issue and requested the return of the units. |
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| Quantity in Commerce | 10 units |
|---|
| Distribution | US and Chile |
|---|
| 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 = CAW
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