Z-0065-2007

Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing...

Name: Z-0065-2007 Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing...
Creator: Smiths Medical MD, Inc.
Published: 2006-09-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-09-27 / Terminated / root cause: sterility

FDA source

Smiths Medical MD, Inc. began a recall of Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2... on 2006-09-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0065-2007
Status: Terminated
Initiated: 2006-09-27
Posted: 2006-10-24
Terminated: 2006-12-30
Recalling firm: Abbott Medical
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 P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4673-24. 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, 2 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.
Product code: MMP Cover, Barrier, Protective
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.
Root cause tag: sterility
FDA root cause: Other
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.
Quantity in commerce: 4 trays
Distribution: CA, FL, MA, MD, OH, OK, TX
Product codes and lots: Lot number M41249

Product code MMP

K942024Class IIPort-a-Cath Low Profile Implantable Venous Access SystemPharmacia Deltec, Inc. / cleared 1994-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)