Rusch/MMG Urinary Catheterization System, 14 Fr recallZ-1083-05 · Teleflex Medical · initiated Jul 11, 2005
Terminated All recalls posted in August 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a lack of assurance of sterility for parts of these lots of product.
FDA root cause category: Other
What the company is doing
Teleflex Medical sent their customers recall letters dated July 11, 2005 via UPS, 2 Day Delivery, on July 13, 2005. The customers were informed that there were documentation discrepancies for the two lots which impact the level of assurance that all of the units are sterile, and were instructed to remove and quarantine all affected product immediately and return the product to Teleflex Medical at Research Triangle Park, NC. Any questions were directed to Dan Daily at 1-800-334-9751, ext. 4029. The recall was extended to include the two additional lots by letter dated 11/15/05. The customers were informed that there were documentation discrepancies for the two lots which impact the level of assurance that all of the units are sterile, and were instructed to remove and quarantine all affected product immediately and return the product to Teleflex Medical at Durham, NC. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Recall details
- Recall number
- Z-1083-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 11, 2005
- Posted by the FDA
- Aug 4, 2005
- Recalling firm
- Teleflex Medical
- Quantity
- 95,800 units
- Product code
- FCM
- FDA submissions
- K010420
- Distribution
- Nationwide
Product description
Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; Rusch, 2450 Meadowbrook Pwy, Duluth, GA 30096, Assembled in Mexico from U.S. Components; product number RLA-142-3
Code information (models, lots, serial numbers)
product number RLA-142-3, lot 002990-6, exp. 2007/03 and lot 002990-7, exp. 2007/02; the recall was expanded on 11/15/05 to include lot numbers 004622-3 and 004622-4
Other devices under the same FDA submission
1 device cleared under K010420 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RUSCH IPN050116Teleflex Incorporated · CATHETER, UROLOGICAL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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