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Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit recallZ-2894-2011 · Arrow International Inc · initiated Jun 17, 2011

Terminated All recalls posted in July 2011

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 Arrow International 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

Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed.

FDA root cause category: Packaging

What the company is doing

Arrow International, Inc. sent an "Urgent Medical Device Recall" letter dated June 17, 2011 to all affected customers. The letter describes the problem and provides recommendations including; quarantine affected product, return of product, and send an acknowledgement form back to manufacturer. For additional information call 800 233-3187.

Recall details

Recall number
Z-2894-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 17, 2011
Posted by the FDA
Jul 29, 2011
Recalling firm
Arrow International Inc
Quantity
95 kits
Product code
CAZ
FDA submissions
K030937
Distribution
Nationwide Distribution including the state of North Carolina.

Product description

Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

Code information (models, lots, serial numbers)

Lot # MF0126544

Other devices under the same FDA submission

2 devices cleared under K030937 — 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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