Free Flow
12.5F X 12CM IJ Free Flow Catheter SET W/Stylet AND W/3 Dilators
2manufacturers in China registered for this device type
27catalogue numbers in this listing
8510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Medical Components Inc, United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-08-13 |
| Record revised | 2021-04-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5 |
| Distribution end date | 2021-04-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MFFS1524S | In distribution | |
| MR541581 | In distribution | |
| MR541574 | In distribution | |
| MR541552 | In distribution | |
| MFFS1515S | In distribution | |
| MR541553 | In distribution | |
| MFFS1224S | In distribution | |
| MR541583 | In distribution | |
| MFFS1215IJ | In distribution | |
| JDFFT-20C | In distribution | |
| MR541573 | In distribution | |
| MR541571 | In distribution | |
| MFFS1220IJ | In distribution | |
| MFFS1215S | In distribution | |
| MR541563 | In distribution | |
| MR541582 | In distribution | |
| MFFS1520S | In distribution | |
| MFFS1212IJ | In distribution | |
| MR541554 | In distribution | |
| MFFS1220S | In distribution | |
| MR541572 | In distribution | |
| JDFFT-24C | In distribution | |
| MR541505 | Withdrawn | |
| MR541503 | Withdrawn | |
| MR541502 | Withdrawn | |
| MR541501 | Withdrawn | |
| MR541504 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 406 |
| Split Cath® III | Medical Components Inc | 277 |
| Palindrome | Mozarc Medical US LLC | 139 |
| Titan HD | Medical Components Inc | 75 |
| ProGuide™ | Merit Medical Systems, Inc. | 72 |
| Hemo-Flow® | Medical Components Inc | 65 |
| DuraMax® | Merit Medical Systems, Inc. | 55 |
| CentrosFLO® | Merit Medical Systems, Inc. | 51 |
| BioFlo DuraMax® | Merit Medical Systems, Inc. | 51 |
| BioFlo | Navilyst Medical, Inc. | 45 |
| DuraFlow | AngioDynamics, Inc. | 37 |
| Mahurkar | Mozarc Medical US LLC | 37 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121848 | 2012-09-21 |
| K113487 | 2012-03-09 |
| K111651 | 2011-12-08 |
| K012562 | 2002-02-08 |
| K994105 | 2001-10-03 |
| K003207 | 2001-06-12 |
| K981125 | 1999-02-26 |
| K971925 | 1998-02-23 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-07-27 | Class II | Under Investigation by firm | Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer | 132 eaches | 2021-04-30 |
| 2015-02-05 | Class II | Process control | Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (bi | 3152 | 2015-08-06 |
| 2014-08-04 | Class II | Labeling False and Misleading | The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM. | 110 | 2014-12-10 |
| 2011-05-19 | Not classified | Mixed-up of materials/components | Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer. | 90 | 2016-10-24 |
| 2009-09-02 | Not classified | Employee error | mislabeled as right are actually left | 100 trays | 2010-04-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.