Jackson-Pratt Silicone Round Drain, 7FR. 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
FDA Recall Z-2145-2017 · Posted None
Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodeGBX
Date Initiated2017-04-21
Date Terminated2017-12-27
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.
Firm Action
CardinalHealth sent an Urgent Product Recall letter dated April 21, 2017, to all affected customers (including response firm). Customers were instructed to inspect recalled lots and return any affected product found. Distributors were instructed to notify their customers. Affected product will be destroyed. To arrange for return of any affected product by contacting Customer Service
at the following numbers:
Hospital800.964.5227
Distributor800.635.6021
Federal Government800.444.1166
All Other Customers888.444.5440
Customers with questions were instructed to contact Cardinal Health Customer Advocacy at 800-292-9332.
For questions regarding this recall call 847-887-4138.
Root Cause
Process design
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.