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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-0066-2007 · Posted 2006-10-24

Recalling FirmSmiths Medical MD, Inc.
Recall StatusTerminated
Product CodeMMP
Date Initiated2006-09-27
Date Terminated2006-12-30
Product Quantity1 tray

Reason for Recall

Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.

Firm Action

An Urgent Product Safety & Recall Notification, dated 09/27/06, was sent to customers via facsimile and phone calls were made. The letter describes the issue and customers are given 3 options to include: use only the sterile tray and discard the wand cover, 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

CA, FL, MA, MD, OH, OK, TX

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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