Z-1713-2009

SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d .038" (.965...

Name: Z-1713-2009 SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d .038" (.965...
Creator: St. Jude Medical
Published: 2009-06-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-06-24 / Terminated / root cause: labeling and UDI

FDA source

St. Jude Medical began a recall of SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude... on 2009-06-24. The reason FDA records is "St. Jude Medical has initiated a voluntary recall of two lots of Peel l Away Introducers . Isolated lots could contain some items that have been mis-labelled with the incorrect French size of the outer box label. Some...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1713-2009
Status: Terminated
Initiated: 2009-06-24
Posted: 2009-08-17
Terminated: 2012-03-29
Recalling firm: Abbott Medical
Product: SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO, Rx only. Intended for use for the introduction of catheters into a vessel.
Product code: DQX Wire, Guide, Catheter
Reason for recall: St. Jude Medical has initiated a voluntary recall of two lots of Peel l Away Introducers . Isolated lots could contain some items that have been mis-labelled with the incorrect French size of the outer box label. Some 9F products have been labelled as 7F and vice versa. Only the outer box label is affected by this error, the labels on the individual product pouches correctly identify the product. St Jude Medical has not received any reports of injures resulting from this mislabelling to date.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The Consignee was provided with a St. Jude Medical "Urgent Product Information" letter and a doctor Acknowledgement form, via e-mail on June 2009. The letter described the problem and the product involved and advised to isolate and discontinue use of the product involved. The Consignee will notify the end user and remove any remaining affected units and will notify St Jude Medical of the results.
Quantity in commerce: 200
Distribution: OUS only: Belgium.
Product codes and lots: Lot Number: 2694227.

Product code DQX

K791129Class IIPermanent Lead IntraducerDaig Corp. / cleared 1979-07-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)