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Turbovac Suction Wand - Reprocessed Sterile device --… recallZ-1669-2008 · Ascent Healthcare Solutions, Inc. · initiated Mar 11, 2008

Terminated All recalls posted in September 2008

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 Ascent Healthcare Solutions, 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

Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

FDA root cause category: Process control

What the company is doing

A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at [email protected].

Recall details

Recall number
Z-1669-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 11, 2008
Posted by the FDA
Sep 19, 2008
Recalling firm
Ascent Healthcare Solutions, Inc.
Quantity
8 of 8
Product code
HRX
FDA submissions
K043198
Distribution
Class II Recall - Nationwide Distribution.

Product description

Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic Arthroscope.

Code information (models, lots, serial numbers)

Catalog No AS1335-01, Lot No 135992.

Other devices under the same FDA submission

1 device cleared under K043198 — 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 47343).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page