Fast-Cath Transseptal Guiding Introducer recall: Labeling Error
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN…
Why was Fast-Cath Transseptal Guiding Introducer recalled?
St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model no. 406586 Batch no. 3619533
- Product
- Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN…
- Recalling firm
- St Jude Medical Inc
- Quantity
- 26
- Distribution
- US Distribution only including the states of FL, KY and OK.
- Recall date
- January 9, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)