Jackson-Pratt Silicone Flat Drain — Class II medical device recall Z-2143-2017
Terminated recall by Cardinal Health 200, LLC, reported 2017-05-31, distributed nationwide. Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of im
| Recall number | Z-2143-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2017-04-21 |
| Classified | 2017-05-23 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2017-12-27 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| Lot numbers | 1161230, 1161231, 1161232, 1161233, 1161234, 1161398, 1161399, 1161400, 1161401, 1161402, 1161403, 1161404, 1161492, 1161493, 1161494, 1161495, 1161496, 1161497, 1161498, 1161499, 1161614, 1161615, 1161616, 1161617, 1170076, 1170077, 1170080 |
| Model numbers | SU130-1310 |
Product
Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Reason for recall
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
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-2143-2017. 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.