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Recall Observatory FDA recall evidence

Device product

Jackson-Pratt PVC Round Drain, 10FR W/Trocar. 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-2140-2017

April 21, 2017

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 77127
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2140-2017

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: SU130-0521 Lot Numbers: 1161481 1170193 1170194

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    seal possibly compromised, potentially compromising the sterility