Permanent Lead Intraducer

• 2 recalls, same reason

  • Terminated Z-2229-2009 FDA Unclassified (pre-2012) ·initiated 17 Aug 2009 ·via K791129, on the same 510(k)
  • Terminated Z-2228-2009 FDA Unclassified (pre-2012) ·initiated 17 Aug 2009 ·via K791129, on the same 510(k)

  St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify the content of the pouch. In another case, the carton label is incorrect. The pouch label indicated that the product was 4F catheter, but the contents of the pouch may be a 7F catheter. St. Jude Medical has not received any reports of injuries resulting from this mis-labeling.

• • Terminated Z-1713-2009 FDA Unclassified (pre-2012) ·initiated 24 Jun 2009 ·via K791129, on the same 510(k)

  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.

• • Terminated Z-1714-2009 FDA Unclassified (pre-2012) ·initiated 24 Jun 2009 ·via K791129, on the same 510(k)

  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.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K791129 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Adapter Kit

  Class II

  FDA 510(k) K781864 Active Cleared 19 Dec 1978

• Pacemaker, Perm. & Temp., Electrode

  Class III

  FDA 510(k) K772197 Active Cleared 30 Jan 1978

• Permanent Lead Intraducer

  Class II

  FDA 510(k) K800356 Active Cleared 28 May 1980

• Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K800352 Active Cleared 28 May 1980

• Daig Pacel(Tm) Flow Directed Pacing Catheter

  Class II

  FDA 510(k) K890794 Active Cleared 20 Jun 1989

• Unipolar Lead Configuration Conductor

  Class III

  FDA 510(k) K800348 Active Cleared 28 May 1980

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