FDA Device recall Z-2141-2017
Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts
- FDA Device
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts 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-2141-2017 |
| 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 Flat Drain, 7mm, 3/4 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
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: SU130-1308 Lot Numbers: 1161228 1161229 1161396 1161397 1161490 1161491 |
|---|
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-2141-2017%22
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