Molded Products, Inc. MPC-130Recalls & reported problems
Molded Products, Inc. · See Luer Cap Set · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B144MPC1300), received between Feb 11, 2026 and Jun 17, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K925927); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Device Misassembled During Manufacturing /Shipping
AN ORIGINAL REPORT WAS CREATED ON (B)(6) 2026; EVENT # (B)(4); A PRODUCT RECALL WAS INITIATED AT THAT TIME. MOLDED PRODUCTS WAS ADVISED (B)(6) 2026 THAT A NEW EVENT HAD OCCURRED THAT INCLUDED THE SAME PRODUCT MANUFACTURED BY MOLDED PRODUCTS. MPC-130 SEE LUER CAP SET LOT# 20389 WAS DEEMED NONCONFORMING DUE TO BEING ASSEMBLED INCORRECTLY. THE LUER PIN WAS NOT SNAPPED INTO THE THREAD CAP WHICH WOULD CAUSE THE TWO PIECES TO DISENGAGE. THIS NONCONFORMANCE IS EASILY SPOTTED AS THE LUER PIN WILL COME OUT AS SOON AS THE CAP IS SCREWED ONTO THE CATHETER OR IT WILL ALREADY BE DISASSEMBLED IN THE PACKAGE. A PROCEDURALIST AT A RADIOLOGY SUITE DID NOT NOTICE THE NONCONFORMANCE AND PROCEEDED TO USE THE PRODUCT ON A PATIENT. THE PRODUCT SHOULD NOT HAVE BEEN AVAILABLE FOR USE AS IT HAD BEEN DOCUMENTED FOR RECALL, AND ALL DISTRIBUTORS HAD BEEN CONTACTED WITH THE RECALL INFORMATION. THE PATIENT HAD TO HAVE AN ADDITIONAL PROCEDURE DONE TO REPLACE A POTENTIALLY CONTAMINATED DIALYSIS LINE NO BLOOD LOSS NOTED AND NO REPORTED INJURY NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535537 ↗MalfunctionFeb 11, 2026Device Misassembled During Manufacturing /Shipping
CLINIC PERSONNEL NOTED ON (B)(6) 2025 WHILE REMOVING THE SEE LUER CAP SET MPC-130 FROM ITS BAG, THAT THE THREADED SLEEVE WAS NOT ENGAGED WITH THE LUER PIN.THE HEALTH WORKER SET ASIDE THE PART AND OBTAINED A NEW PART. NO DIRECT PATIENT INVOLVEMENT WAS NOTED. THIS EVENT WAS REPORTED TO MOLDED PRODUCTS 12/08/2025 AN INVESTIGATION WAS IMMEDIATELY OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24318216 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K925927. One submission often covers many models, so check the product and lot details in each record.
- Z-1774-2026 · Feb 17, 2026 · Open, ClassifiedSee Luer Cap Set, MPC-130, set, administration, intravascular
- Z-2354-2019 · Jun 10, 2019 · TerminatedLuer Lock Set - Catalog # MPC-125, for IV administration sets.
Other Set, Administration, Intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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