SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d .038" (.965 mm), conten
FDA device recall Z-1713-2009 · posted 2009-08-17 · Terminated
Recall details
- Recalling firm
- St. Jude Medical
- 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.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 200
- Distribution
- OUS only: Belgium.
- Date initiated
- 2009-06-24
- Date posted
- 2009-08-17
- Date terminated
- 2012-03-29
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERMANENT LEAD INTRADUCER (K791129) | Daig Corp. | 1979-07-17 |