Arrow
Peritoneal Lavage Kit
1manufacturer
8catalogue 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 |
| 510(k) | K811627 |
| Record published | 2022-11-09 |
| Record revised | 2025-12-15 (version 7) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 20 to 25 °C; Special storage condition: Store between 20 – 25°C (68 – 77°F). Avoid freezing and excessive heat above 40°C (104°F). |
| Packaging | Case of 10 |
| Sizes | Catheter gauge 8 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN920801 | In distribution | |
| IPN032636 | In distribution | |
| IPN032635 | Catheter Gauge 8 Fr | In distribution |
| IPN033870 | In distribution | |
| IPN036986 | In distribution | |
| IPN915668 | In distribution | |
| IPN036986 | In distribution | |
| IPN032635 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jackson-Pratt | Cardinal Health 200, LLC | 28 |
| Cook | Cook Incorporated | 22 |
| Tenckhoff | Cook Incorporated | 13 |
| Taut | Teleflex Medical LLC | 13 |
| Core Dynamics | ConMed Corporation | 9 |
| Silicone Sump Drain Tube | Fortune Medical Instrument Corp. | 9 |
| 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 Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2026-04-21 | Class I | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-bas | 7560 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2004-08-02 | Not classified | Other | wrong introducer needle in some kits | 9100 units | 2005-08-22 |
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.