Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG… — Class II medical device recall Z-1370-2019
Terminated recall by Cook Inc., reported 2019-05-29, distributed nationwide. Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use
| Recall number | Z-1370-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2019-04-22 |
| Classified | 2019-05-17 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2020-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, IE, IL, IT, JO, LT, MA, NL, NZ, PL, QA, RO, SA, SE, SI, SK, TH, TR, UA, ZA |
| Quantity | 3,711 |
| Model numbers | 4.0, 4.7, G18168, G32773, G32774, SIPSF-040018-56-6, SIPSF-040018-59, SIPSF-050018-59 |
Product
Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774
Reason for recall
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1370-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.