—#155235

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

FDA product code: GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog Number: SU130-0521 Lot Numbers: 1161481 1170193 1170194

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 1500 S Waukegan Rd, Waukegan, Illinois 60085-6728

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2017-04-21
Terminated: 2017-12-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155235. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.