Z-2146-2017 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 Silicone Round Drain, 10FR. 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: SU130-1321 Lot Numbers: 1161206 1161207 1161370 1161371 1161372 1161476 1161477 1161478 1161606 1161607 1161608 1170036