Recall Z-2354-2019
Molded Products Inc · initiated June 10, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Luer Lock Set - Catalog # MPC-125, for IV administration sets.
Codes / lots: LOT NUMBER: 20266 UDI # +B144MPC1251/$$52232420266N Expiration Date 11/20/2022
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: Packaging process control
Action taken
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.
Details
- Recall number
- Z-2354-2019
- Initiated
- June 10, 2019
- Terminated
- May 28, 2021
- Product code
- FPA – Set, Administration, Intravascular
- Quantity
- 130,000 sets
- Distribution
- Distribution US nationwide.
- Recalling firm
- Molded Products Inc, Harlan, IA