Z-2391-2008

Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to...

Name: Z-2391-2008 Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to...
Creator: Apogee Medical, Inc
Published: 2008-07-17
License: https://open.fda.gov/license/

Robling Medical, LLC / initiated 2008-07-17 / Terminated / root cause: packaging

FDA source

Apogee Medical, Inc began a recall of 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... on 2008-07-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2391-2008
Status: Terminated
Initiated: 2008-07-17
Posted: 2008-09-21
Terminated: 2009-06-04
Recalling firm: Robling Medical, LLC
Product: 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.
Product code: GBM Catheter, Urethral
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 5400 pcs
Distribution: U.S. Nationwide and Canada
Product codes and lots: Lot number 7206

Product code GBM

K992137Class IIUrological CatheterApogee, Inc. / cleared 1999-09-03

Hollister recalls 2.5 million intermittent catheters over a manufacturing defect11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)