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U.S. Department of Health and Human Services

Class 2 Device Recall LocatorWand Cover

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  Class 2 Device Recall LocatorWand Cover see related information
Date Initiated by Firm March 29, 2006
Date Posted April 27, 2006
Recall Status1 Terminated 3 on January 23, 2007
Recall Number Z-0800-06
Recall Event ID 35148
510(K)Number K932840  K931073  K871132  
Product Classification Cover, Barrier, Protective - Product Code MMP
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, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4653-24. 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 21-4653-24, Lot numbers: M42229, M42693, M42899, M43378.
Recalling Firm/
Manufacturer		 Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
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.
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 189 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
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.
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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