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.
This recall has been terminated (originally issued August 17, 2009).
- Company
- St. Jude Medical
- Recall Initiated
- June 24, 2009
- Posted
- August 17, 2009
- Terminated
- March 29, 2012
- Recall Number
- Z-1714-2009
- Quantity
- 200
- Firm Location
- Minnetonka, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
OUS only: Belgium.
Lot / Code Info
Lot Number: 2694252.
Root Cause
Labeling mix-ups
Action Taken
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.