FDA Device recall Z-2145-2017
Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only
- FDA Device
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only by Cardinal Health 200, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2145-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-21 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Jackson-Pratt Silicone Round Drain, 7FR. 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
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.
Identifiers
| code_info | Catalog Number: SU130-1320 Lot Numbers: 1161205 1161368 1161369 1161475 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2145-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.