| Date Initiated by Firm | January 20, 2015 |
|---|
| Date Posted | March 24, 2017 |
|---|
| Recall Status1 |
Terminated 3 on March 30, 2017 |
| Recall Number | Z-1679-2017 |
|---|
| Recall Event ID |
76760 |
| 510(K)Number | K003712 |
|---|
| Product Classification |
Accessories, blood circuit, hemodialysis - Product Code KOC
|
| Product | Non-Sterile Double DIN to DIN "Y" Connector,
Product Usage:
Extension for connecting hemodialysis blood tubing to the hemodialyzer. |
|---|
| Code Information |
40013 |
| FEI Number |
1000138417
|
Recalling Firm/
Manufacturer |
Molded Products Inc
1112 Chatburn Ave
Harlan
IA
51537-2007
|
| For Additional Information Contact | Sheri Tyrrel
712-755-5557 |
|---|
Manufacturer Reason
for Recall | A customer relayed a complaint of a leaking dialysis tubing connector. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | On 1/20/2015, the recalling firm requested the firm's customer to return units from the affected lot. |
|---|
| Quantity in Commerce | 400 pieces |
|---|
| Distribution | Product was distributed to Ontario, Canada. |
|---|
| 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 = KOC
|
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