Device 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
Z-2143-2017
Product summary
- Event
- Event 77127
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2143-2017
Official wording
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.
Code information: Catalog Number: SU130-1310 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
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Sterility assurance
seal possibly compromised, potentially compromising the sterility