Recall Z-1714-2009 ยท DQX Wire, Guide, Catheter
St. Jude Medical
SJM Peel Away Introducer, REF 405153, Lot 2694252, Length 14 cm, 7F (2.33 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.
| Date | Aug 17, 2009 (initiated Jun 24, 2009) |
| Status | Terminated |
| Reason | St. Jude Medical has initiated a voluntary recall of two lots of Peel 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 | 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 | 200 |
| Distribution | OUS only: Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791129 | PERMANENT LEAD INTRADUCER Daig Corp., Jul 17, 1979 |