Recall Z-2140-2017— Cardinal Health 200, LLC

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2017-04-21, terminated 2017-12-27. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..

Recalling firm

Cardinal Health 200, LLC

Classification

Class II

Status

Terminated

Initiated

2017-04-21

Terminated

2017-12-27

Firm location

Waukegan, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.