FDA Medical Device Recalls (openFDA)
Teleflex Medical: RUSCH, GB: Female Catheter, All Purpose PVC, 10 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.
- Recall number
- Z-2933-2011
- Recalling firm
- Teleflex Medical
- Product
- RUSCH, GB: Female Catheter, All Purpose PVC, 10 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.
- Status
- Terminated
- Initiated
- 2011-06-30
- Posted
- 2011-08-03
- Terminated
- 2014-04-29
- Reason
- Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Root cause
- Other
- Action
- Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template. For questions, contact your local sales representative or call Customer service at 1-866-246-6990
- Quantity
- See line 1.
- Distribution
- Worldwide Distribution and (USA) Nationwide Distribution.
- Lot, serial or model codes
- Product number: 238300100, Lot numbers: 18754, 19225, 19910, 22276, 22277, 25562, 103029, 105439, 113974, 116419, 118754, 119225, 119910, 122276, 122277, 123172, 125562, 142573, 142574, 310434, 322168, 335515, 340212, 342045, 346326, 350056, 359273, 359990, 378591, 378592, 379600, 380079, 380255, 380289, 384500, 390490, 391728, 405524 and 411563.
- 510(k) numbers
- ["K896729"]
- PMA numbers
- not on file
- Product code
- KOD
- Firm FEI
- 3005747797
- Firm city
- Durham
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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