Z-2886-2011

* EXPANDED RECALL * Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter...

Name: Z-2886-2011 ***** EXPANDED RECALL ***** Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter...
Creator: Teleflex Medical
Published: 2011-06-02
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2011-06-02 / Terminated / root cause: sterility

FDA source

Teleflex Medical began a recall of ***** EXPANDED RECALL ***** Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter, Manufactured for and distributed by Teleflex... on 2011-06-02. The reason FDA records is "Sterile integrity cannot be guaranteed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2886-2011
Status: Terminated
Initiated: 2011-06-02
Posted: 2011-06-27
Terminated: 2013-04-05
Recalling firm: Teleflex Medical
Product: ***** EXPANDED RECALL ***** Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter, Manufactured for and distributed by Teleflex Medical, Research Triangle Park, NC 57708 Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.
Product code: FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Reason for recall: Sterile integrity cannot be guaranteed.
Root cause tag: sterility
FDA root cause: Other
Action: Teleflex Medical sent an " URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 2, 2011. The letter identified the product, the problem and the actions needed to be taken. The customers were instructed to immediately discontinue distribution, quarantine any affected products, communicate this recall to any of their customers using the provided customer letter, and complete and fax the enclosed Recall Acknowledgement Form to Customer Service at 1-866-804-9881. Once the fax is received instructions for product return will be provided to customers. In the event that an alternative approach is needed, customers are instructed to contact Teleflex Medical Customer Service at 1- 866-246-6990. For further questions contact your sales representative or Customer Service at 1-866-246-6990. The recall was expanded and an additional letter was sent out on July 20, 2011 to the affected consignees with the above instructions. *****RECALL EXPANDED***** Product 2. Teleflex sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated July 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. On July 19, 2011 this recall was expanded to include additional product. Please see above strategy information for details
Quantity in commerce: see line 1.
Distribution: Nationwide Distribution: AZ, CA, FL, GA, IL, KS, KY, LA, MA, MS, NC, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WI including Puerto Rico.
Product codes and lots: Catalogue number: 76816, Lot number 0J005.

Product code FAQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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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)