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6f Z2 Guiding Catheter Sr4.0 recallZ-1026-06 · Medtronic, Inc. · initiated Apr 5, 2006

Terminated All recalls posted in June 2006

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 Medtronic, Inc. 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

Potential for non-sterility due to loss of package integrity

FDA root cause category: Other

What the company is doing

Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.

Recall details

Recall number
Z-1026-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 5, 2006
Posted by the FDA
Jun 1, 2006
Recalling firm
Medtronic, Inc.
Quantity
645 units
Product code
DQY
FDA submissions
K010579
Distribution
Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.

Product description

6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR40

Code information (models, lots, serial numbers)

Lot Numbers: 0000002433 0000006514 0000012046 0000027687 0000028673 0000033680 0000033718 0000043780 0000046956 0000067140 0000072965 0000076643 0000080168 0000081106 0000085973 0000095150 0000106493 0000134505 0000172339 178512 182950 186089 202512 205561 208500 211542 214599 215763 221279 222892

Other devices under the same FDA submission

3 devices cleared under K010579 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 35236).

Sources and updates

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