| Date Initiated by Firm | June 10, 2019 |
|---|
| Create Date | August 22, 2019 |
|---|
| Recall Status1 |
Terminated 3 on May 28, 2021 |
| Recall Number | Z-2354-2019 |
|---|
| Recall Event ID |
83330 |
| 510(K)Number | K925927 |
|---|
| Product Classification |
Set, administration, intravascular - Product Code FPA
|
| Product | Luer Lock Set - Catalog # MPC-125, for IV administration sets. |
|---|
| Code Information |
LOT NUMBER: 20266 UDI # +B144MPC1251/$$52232420266N Expiration Date 11/20/2022 |
Recalling Firm/
Manufacturer |
Molded Products Inc
1112 Chatburn Ave
Harlan IA 51537-2007
|
| For Additional Information Contact | Customer/Technical Support
800-435-8957 |
|---|
Manufacturer Reason
for Recall | Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150. |
|---|
FDA Determined
Cause 2 | Packaging process control |
|---|
| Action | On June 10, 2019, the firm sent URGENT MEDICAL DEVICE RECALL letters to their consignees advising them of the labeling problem, requesting that they check their stock, notify their end users and complete the attached MEDICAL DEVICE RECALL CUSTOMER RESPONSE FORM. |
|---|
| Quantity in Commerce | 130,000 sets |
|---|
| Distribution | Distribution US nationwide. |
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| 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 = FPA
|
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