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U.S. Department of Health and Human Services

Class 2 Device Recall JacksonPratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar.

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  Class 2 Device Recall JacksonPratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. see related information
Date Initiated by Firm April 21, 2017
Create Date May 23, 2017
Recall Status1 Terminated 3 on December 27, 2017
Recall Number Z-2135-2017
Recall Event ID 77127
Product Classification Catheter, irrigation - Product Code GBX
Product Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR 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
Code Information Catalog Number: JP-HUR151 Lot Numbers: 1161195 1161196 1161360 1161456 1161593 1170021 1170022
Recalling Firm/
Manufacturer
Cardinal Health 200, LLC
1500 S Waukegan Rd
Waukegan IL 60085-6728
For Additional Information Contact Customer Advocacy
800-292-9332
Manufacturer 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 2
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 Advocacy at 800-292-9332. For questions regarding this recall call 847-887-4138.
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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