CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
Luer Lock Set recalled by Molded Products
Molded Products is recalling Luer Lock Set, distributed nationwide in the US. The recall was initiated on 10 Jun 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2354-2019
- FDA event ID
- 83330
- Recalling firm
- Molded Products, Harlan, IA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2019
- FDA classified
- 22 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Infusion Pumps
Timeline
| 10 Jun 2019 | Recall initiated by company | |
| 22 Aug 2019 | Classified by FDA | +73 days |
| 28 Aug 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Luer Lock Set - Catalog # MPC-125, for IV administration sets.
Where it was distributed
Distribution US nationwide.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
LOT NUMBER: 20266 UDI # +B144MPC1251/$$52232420266N Expiration Date 11/20/2022
Where was it sold?
Distribution US nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Molded Products
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | See Luer Cap Set, MPC-130, set, administration, intravascular recalled | Molded Products | Other | Nationwide |
| Device | CLASS II | Non-Sterile Double DIN to DIN "Y" Connector recalled by Molded Products | Molded Products | Packaging Defects | IA |
| Device | CLASS II | Sterile Access & Return Line Set, 36" Length, Part # UM recalled | Molded Products | Packaging Defects | MI |
Other Infusion Pumps recalls
All 549| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl | BD Switzerland Sarl | Other | Nationwide |
| Device | CLASS II | IV Non-Dedicated Gravity Administration Sets with drip chambers recalled | ICU Medical | Foreign Material | Nationwide |
| Device | CLASS II | Plum administration sets recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |