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7f Zuma 2 Sr4.0 Sh 100cm recallZ-1039-06 · 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-1039-06
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
50 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

7F ZUMA 2 SR4.0 SH 100CM CATHETER Z27SR40SH Z2 7F 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 Number: Z27SR40SH

Code information (models, lots, serial numbers)

Lot Numbers: 0000027588 0000027596 0000028599 0000183448

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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