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Class 2 Device Recall LocatorWand Cover |
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Date Initiated by Firm |
March 29, 2006 |
Date Posted |
April 27, 2006 |
Recall Status1 |
Terminated 3 on January 23, 2007 |
Recall Number |
Z-0804-06 |
Recall Event ID |
35148 |
510(K)Number |
K942024 K931073 K871132
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Product Classification |
Cover, Barrier, Protective - Product Code MMP
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Product |
Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A. |
Code Information |
Re-order number 21-4683-24, Lot numbers: M41020, M41851, M42231, M42434, M42880, M43365 |
Recalling Firm/ Manufacturer |
Smiths Medical MD, Inc. 1265 Grey Fox Rd Saint Paul MN 55112-6929
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Manufacturer Reason for Recall |
One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover is placed on the outside of the PORT-A-CATH II AND P.A.S. PORT tray.
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FDA Determined Cause 2 |
Other |
Action |
An Urgent Product Safety & Recall Notification, dated 03/29/06, was mailed to domestic customers and emailed to international customers. The letter described the issue, identified re-order number and lot numbers affected and gave 3 options. The options include to use only the sterile tray and discard the wand cover from the shelf box; remove and discard Locator-Wand Cover pouches and request replacement Locator-Wand Covers; or return the entire device for a credit or replacement. |
Quantity in Commerce |
506 trays |
Distribution |
Nationwide. AR, CA, DE, FL, IL, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OK, PA, TN, TX, VA, WI. Germany, Italy, Netherlands, Singapore, Spain |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = MMP and Original Applicant = DELTEC SYSTEMS, INC. 510(K)s with Product Code = MMP and Original Applicant = PHARMACIA DELTEC, INC.
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