Taut
Weck Vista Mini Port 3.3 Millimeter X 8.9 Centimeter Smooth
1manufacturer
13catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GBW |
| Device type | Catheter, Peritoneal |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-19 |
| Record revised | 2021-01-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, case of 10 |
| Sizes | Depth 0.25 to 0.5 in; width 0.5 to 2 in; length 5.1 to 9.1 in; width 3.3 mm; length 8.9 cm |
| Distribution end date | 2025-09-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN927862 | Depth 0.25 in | In distribution |
| IPN029604 | Length 6 in | In distribution |
| IPN029602 | Depth 0.5 in | In distribution |
| IPN023873 | Width 0.5 in | In distribution |
| IPN023878 | Width 2 in | In distribution |
| IPN927865 | Width 0.5 in | In distribution |
| IPN023877 | Length 5.2 in | In distribution |
| IPN029601 | Width 0.5 in | In distribution |
| IPN927864 | Length 5.1 in | In distribution |
| IPN927863 | Length 6 in | In distribution |
| IPN023872 | Length 5.1 in | In distribution |
| IPN029603 | Length 5.2 in | In distribution |
| IPN004935 | Width 3.3 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jackson-Pratt | Cardinal Health 200, LLC | 28 |
| Cook | Cook Incorporated | 22 |
| Tenckhoff | Cook Incorporated | 13 |
| Core Dynamics | ConMed Corporation | 9 |
| Silicone Sump Drain Tube | Fortune Medical Instrument Corp. | 9 |
| Arrow | Teleflex Medical LLC | 8 |
| Merit Medical® | Merit Medical Systems, Inc. | 5 |
| Grafco | GF Health Products, Inc | 5 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Malecot | Boston Scientific Corporation | 3 |
| DeRoyal | Deroyal Industries, Inc. | 2 |
| Stenting Malecot | Boston Scientific Corporation | 2 |
Showing 12 of 15. All products under Catheter, Peritoneal
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-10-14 | Class II | Nonconforming Material/Component | The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device. | 2050 ea. | 2017-12-11 |
| 2012-07-20 | Class III | Packaging process control | Product is missing the label on the internal packaging. | 611 units | 2015-02-12 |
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.