Summary
The FDA issued a Class II for See Luer Cap Set, MPC-130, set, administration, intravascular by Molded Products Inc. Reason: Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded.
Details
Source
Device Recall
External ID
Z-1774-2026
Action Date
2026-04-15
Status
Ongoing
Category
device
Product Description
See Luer Cap Set, MPC-130, set, administration, intravascular
Lot/Code Info: UDI +B144MPC1300/$$529105203895, Lot Number 20389
Quantity Affected: 26900 units
Reason for Recall
Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.
Distribution
US Nationwide distribution in the states of TN, TX, NV, IL, FL.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-17
Company
Harlan, IA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 232 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Molded Products Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Molded Products Inc have FDA actions?
This is the only FDA action we have on record for Molded Products Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1774-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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