Z-2135-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- April 21, 2017
- Termination Date
- December 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR 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
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.
Distribution Pattern
Nationwide Distribution
Code Information
Catalog Number: JP-HUR151 Lot Numbers: 1161195 1161196 1161360 1161456 1161593 1170021 1170022