FDA Medical Device Recalls (openFDA)
Molded Products Inc: Luer Lock Set - Catalog # MPC-125, for IV administration sets.
- Recall number
- Z-2354-2019
- Recalling firm
- Molded Products Inc
- Product
- Luer Lock Set - Catalog # MPC-125, for IV administration sets.
- Status
- Terminated
- Initiated
- 2019-06-10
- Posted
- not on file
- Terminated
- 2021-05-28
- Reason
- 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.
- Root cause
- 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
- 130,000 sets
- Distribution
- Distribution US nationwide.
- Lot, serial or model codes
- LOT NUMBER: 20266 UDI # +B144MPC1251/$$52232420266N Expiration Date 11/20/2022
- 510(k) numbers
- K925927
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1000138417
- Firm city
- Harlan
- Firm state
- IA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28