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Cath. Guide 6f Sr4.0 W/Sh Laun recallZ-0962-06 · 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-0962-06
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
543 units
Product code
DQY
FDA submissions
K021256
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

CATH. GUIDE 6F SR4.0 W/SH LAUN CATHETER LA6SR40SH LA 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: LA6SR40SH

Code information (models, lots, serial numbers)

Lot Numbers: 0000009467 0000017356 0000018656 0000041210 0000051080 0000060714 0000071655 0000074794 0000077721 0000080996 0000082769 0000083088 0000085997 0000093521 0000096040 0000120776 0000152164 178392 186228 201560 201587 212067 214648 218835

Other devices under the same FDA submission

50 devices cleared under K021256 — 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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