Recall Z-2143-2017 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Cardinal Health 200, LLC
Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. 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
| Date | Apr 21, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Process design |
| 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 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.