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Terminated

Luer Lock Set - Catalog # MPC-125, for IV administration sets.

FDA Recall Z-2354-2019 · Posted None

Recalling FirmMolded Products Inc
Recall StatusTerminated
Product CodeFPA
Date Initiated2019-06-10
Date Terminated2021-05-28
Product Quantity130,000 sets

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.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Distribution US nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K925927MPC-1000 INJECTION CAP/PLUGMolded Products, Inc. · 1993-08-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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