FDA Medical Device Recalls (openFDA)
Apogee Medical, Inc: 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.
- Recall number
- Z-2391-2008
- Recalling firm
- Apogee Medical, Inc
- 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.
- Status
- Terminated
- Initiated
- 2008-07-17
- Posted
- 2008-09-21
- Terminated
- 2009-06-04
- Reason
- 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
- 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
- 5400 pcs
- Distribution
- U.S. Nationwide and Canada
- Lot, serial or model codes
- Lot number 7206
- 510(k) numbers
- ["K992137"]
- PMA numbers
- not on file
- Product code
- GBM
- Firm FEI
- 3007829657
- Firm city
- Youngsville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28