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Cath. Guide 6f 3drc W/Sh Launc recallZ-0938-06 · 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-0938-06
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
1514 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 3DRC W/SH LAUNC CATHETER LA63DRCSH LA 6F 100CM 3DRC 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: LA63DRCSH

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Lot Numbers:  0000001683 0000006399 0000010421 0000012409 0000013716 0000017342 0000021394 0000021447 0000023244 0000026985 0000029266 0000029705 0000032466 0000035432 0000037924 0000042889 0000042890 0000043999 0000044001 0000044002 0000044005 0000046318 0000047374 0000051910 0000057225 0000057226 0000057227 0000058402 0000064594 0000064609 0000064622 0000064623 0000064642 0000064644 0000068966 0000068967 0000072109 0000072110 0000074335 0000074336 0000077688 0000077689 0000077723 0000077724 0000080001 0000080002 0000085367 0000088937 0000092144 0000093108 0000095216 0000099873 0000099874 0000100931 0000100932 0000102659 0000106195 0000109513 0000113247 0000118398 0000124586 0000125088 0000132238 0000133516 0000137092 0000149960 0000151195 0000170064 0000173689 0000174400 0000174416 0000175222 0000175235 0000189059 175016 178826 182733 184962 185864 188187 200447 200786 202877 203553 204960 211561 213101 214919 217583 219366 222386 222387

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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