Recall Z-2140-2017
Cardinal Health 200, LLC · initiated April 21, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Catalog Number: SU130-0521 Lot Numbers: 1161481 1170193 1170194
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.
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-2140-2017
- Initiated
- April 21, 2017
- Terminated
- December 27, 2017
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Distribution
- Nationwide Distribution
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2131-2017 Class II | Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2132-2017 Class II | Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only.…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2133-2017 Class II | Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2134-2017 Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2135-2017 Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2136-2017 Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2137-2017 Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only. For…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2138-2017 Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2139-2017 Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2141-2017 Class II | Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2142-2017 Class II | Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2143-2017 Class II | Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2144-2017 Class II | Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2145-2017 Class II | Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only.…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2146-2017 Class II | Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only.…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2147-2017 Class II | Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only.…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2148-2017 Class II | Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only.…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2149-2017 Class II | Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |
| Z-2150-2017 Class II | Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use…Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of… | 04/21/2017Terminated |