FDA Medical Device Recalls (openFDA)
Teleflex Medical: 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
- Recall number
- Z-1083-05
- Recalling firm
- Teleflex Medical
- Product
- 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
- Status
- Terminated
- Initiated
- 2005-07-11
- Posted
- 2005-08-04
- Terminated
- 2007-11-14
- Reason
- There is a lack of assurance of sterility for parts of these lots of product.
- Root cause
- Other
- Action
- 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.
- Quantity
- 95,800 units
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K010420"]
- PMA numbers
- not on file
- Product code
- FCM
- Firm FEI
- 3004959265
- Firm city
- Bannockburn
- Firm state
- IL
- 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
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