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Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No.… recallZ-2391-2008 · Apogee Medical, Inc · initiated Jul 17, 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 Apogee Medical, 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

Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.

FDA root cause category: Packaging process control

What the company is doing

Distributors and Retailers that have received any of the Catalog Numbers listed in the letter titled URGENT MEDICAL DEVICE RECALL were notified on/about July 17, 2008. Recipients of the letter are being requested to review their inventory and return any of the applicable Catalog Items from the specific lot numbers listed in the recall letter. Distributors are being instructed to notify their customers and inform them of the recall with a copy of the recall letter. Their notification should instruct their customers to return the recalled product to them so that they could return the product to Apogee Medical LLC. In addition to the initial letter, follow-up letters, telephone calls and emails will be utilized to assess the effectiveness of the recall. A spreadsheet has been set up and will be maintained in order to easily identify the customers that have been contacted, those who have responded and those who have returned product. If you have questions, contact Diane Peper at 919-435-5409.

Recall details

Recall number
Z-2391-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 17, 2008
Posted by the FDA
Sep 21, 2008
Recalling firm
Apogee Medical, Inc
Quantity
5400 pcs
Product code
GBM
FDA submissions
K992137
Distribution
U.S. Nationwide and Canada

Product description

Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

Code information (models, lots, serial numbers)

Lot number 7206

Other devices under the same FDA submission

1 device cleared under K992137 — 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 49027).

Sources and updates

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