Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter,

FDA device recall Z-1083-05 · posted 2005-08-04 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

There is a lack of assurance of sterility for parts of these lots of product.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FCM

Quantity affected

95,800 units

Distribution

Nationwide

Date initiated

2005-07-11

Date posted

2005-08-04

Date terminated

2007-11-14

Location

Bannockburn, IL

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