Z-1774-2026Class II

See Luer Cap Set, MPC-130, set, administration, intravascular

Name: Z-1774-2026 See Luer Cap Set, MPC-130, set, administration, intravascular
Creator: Molded Products Inc
Published: 2026-02-17
License: https://open.fda.gov/license/

Molded Products Inc / initiated 2026-02-17 / Open, Classified / root cause: manufacturing process

FDA source

Molded Products Inc began a recall of See Luer Cap Set, MPC-130, set, administration, intravascular on 2026-02-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1774-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-17
Posted: 2026-04-06
Recalling firm: Molded Products Inc
Product: See Luer Cap Set, MPC-130, set, administration, intravascular
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Molded Products, Inc. issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 02/17/2026 via USPS First Class Mail. The notice explained the issue and requested the following: Please take the following actions: 1. Please inspect your inventory to determine if you have any of the affected lot. Quarantine the affected product and initiate a return to Molded Products, Inc. for credit. 2. Share this recall notification will all users of the product to ensure they are also aware of this recall. 3. Complete the attached Medical Device Recall Customer Response Form and return to the contact noted below whether or not you have any of the impacted material so that Molded Products may acknowledge your receipt of this notification and process your return and credit. For complaints, adverse events, or questions, contact Teresa Wooster, [email protected]; Ph# 800-435-8957 ext. 236 Monday Friday 8:00am-4:30pm (CT), Fax# 800-227-7935.
Quantity in commerce: 26900 units
Distribution: US Nationwide distribution in the states of TN, TX, NV, IL, FL.
Product codes and lots: UDI +B144MPC1300/$$529105203895, Lot Number 20389

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1774-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1774-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06

Product code FPA

K925927Class IIMpc-1000 Injection Cap/plugMolded Products, Inc. / cleared 1993-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)