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Medtronic, Transfer Spike, Blood Processing Accessory, REF… recallZ-1424-2009 · Medtronic Cardiovascular Revascularization & Surgical Therap · initiated Feb 25, 2009

Terminated All recalls posted in June 2009

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 Cardiovascular Revascularization & Surgical Therap 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

Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death.

FDA root cause category: Device Design

What the company is doing

Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" letter dated March 5, 2009. The letter was addressed to Risk Manager. The letter described the product and problem and requested the consignee to complete, sign and return the certificate acknowledgement.

Recall details

Recall number
Z-1424-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 25, 2009
Posted by the FDA
Jun 23, 2009
Recalling firm
Medtronic Cardiovascular Revascularization & Surgical Therap
Quantity
20 units
Product code
DWE
FDA submissions
K800178
Distribution
Distribution to one medical facility in MN.

Product description

Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits

Code information (models, lots, serial numbers)

Lot 10279571, Use By 2012-01-31

Other devices under the same FDA submission

113 devices cleared under K800178 — 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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