Molded Products Inc
Harlan, IA, US
MOLDED PRODUCTS INC. appears in FDA device records in Harlan, IA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Molded Products Inc between 1993 and 2002. The busiest year on record is 2001, with 3. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1994 | 1 |
| 2001 | 3 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K022068 | TUBING, DIALYSATE (AND CONNECTOR) | FID | Substantially Equivalent | |
| K010366 | DISPOSABLE STORAGE CAP | FJI | Substantially Equivalent | |
| K010712 | DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES | FID | Substantially Equivalent | |
| K003712 | MODIFICATION TO MALE TO MALE LUER ADAPTER | KOC | Substantially Equivalent | |
| K925978 | MPC-80 TRANSDUCER | FIB | Substantially Equivalent | |
| K925930 | MPC-150 MALE TO MALE LUER ADAPTER | FPA | Substantially Equivalent | |
| K925927 | MPC-1000 INJECTION CAP/PLUG | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1932668 | 1000138417 | MOLDED PRODUCTS INC. | 1812 Industrial Pkwy, HARLAN, IA 51537 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- LYUAccessory, Surgical Apparel
- GBMCatheter, Urethral
- HXDClamp
- NOOClamp, Dialysis Arm
- FHAClamp, Penile
- LKYDevice, External Penile Rigidity
- LIFDialyzer Reprocessing System
- FJIDialyzer, Capillary, Hollow Fiber
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- HTDForceps
- GENForceps, General & Plastic Surgery
- FHQHolder, Needle, Gastroenterologic
- FIBProtector, Transducer, Dialysis
- FPASet, Administration, Intravascular
- KPYShield, Protective, Personnel
- MONSystem, Hemodialysis, Remote Accessories
- GAXTourniquet, Nonpneumatic
- FIDTubing, Dialysate
- IKWUtensil, Homemaking
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1774-2026 | See Luer Cap Set, MPC-130, set, administration, intravascular | 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. | Class II | Open, Classified | |
| Z-2354-2019 | Luer Lock Set - Catalog # MPC-125, for IV administration sets. | 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. | Class II | Terminated | |
| Z-1679-2017 | Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer. | A customer relayed a complaint of a leaking dialysis tubing connector. | Class II | Terminated | |
| Z-0969-2013 | Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing. | The recalled product leaks at the connection site. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain