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St. Jude Medical, Fixed Curve Response 6F Electrophysiology… recallZ-0177-2015 · St Jude Medical · initiated Oct 14, 2014

Class II Terminated All recalls posted in November 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from St Jude Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue

FDA root cause category: Labeling mix-ups

What the company is doing

St. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.

Recall details

Recall number
Z-0177-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 14, 2014
Posted by the FDA
Nov 6, 2014
Recalling firm
St Jude Medical
Quantity
26
Product code
DRF
FDA submissions
K894500
Distribution
US Distribution including the states of CA, GA, NJ, NY, OR and PA.

Product description

St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353

Code information (models, lots, serial numbers)

Batch # 4671318

Other devices under the same FDA submission

24 devices cleared under K894500 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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