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Terminated

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.

FDA Recall Z-0804-06 · Posted 2006-04-27

Recalling FirmSmiths Medical MD, Inc.
Recall StatusTerminated
Product CodeMMP
Date Initiated2006-03-29
Date Terminated2007-01-23
Product Quantity506 trays

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K942024PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEMPharmacia Deltec, Inc. · 1994-07-26K931073CATH-FINDERPharmacia Deltec, Inc. · 1994-05-05K871132PHARMACIA DELTEC SUBCLAVIAN INTRODUCERSDeltec Systems, Inc. · 1987-04-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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