Z-2134-2017 Class II Terminated
FDA device recall Z-2134-2017 was initiated by Cardinal Health 200, LLC on April 21, 2017 and is designated Class II. 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. The recall status is terminated (terminated December 27, 2017).
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, 10FR W/10FR 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-HUR101 Lot Numbers: 1161193 1161194 1161359 1161467 1161468 1161591 1161592