Z-2933-2011

RUSCH, GB: Female Catheter, All Purpose PVC, 10 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle...

Name: Z-2933-2011 RUSCH, GB: Female Catheter, All Purpose PVC, 10 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle...
Creator: Teleflex Medical
Published: 2011-06-30
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2011-06-30 / Terminated / root cause: packaging

FDA source

Teleflex Medical began a recall of 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... on 2011-06-30. The reason FDA records is "Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed". 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-2933-2011
Status: Terminated
Initiated: 2011-06-30
Posted: 2011-08-03
Terminated: 2014-04-29
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.
Product code: KOD Catheter, Urological
Reason for recall: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Root cause tag: packaging
FDA 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 in commerce: See line 1.
Distribution: Worldwide Distribution and (USA) Nationwide Distribution.
Product codes and lots: 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.

Product code KOD

K896729Class IINelaton-, Female - or Tiemann CatheterUnoplast A/S / cleared 1990-11-05

MDM coverage of this record lists here, newest first.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)