Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individu

FDA device recall Z-0428-2007 · posted 2007-02-15 · Terminated

Recall details

Recalling firm

Taut, Inc.

Reason for recall

Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.

Action taken

Taut sent Urgent Medical Device Recall letters dated 1/19/07, via UPS over night, on the same date, informing them that the two lots of catheters may have package seals that are not intact. Customers were instructed to check their stocks for the affected lots, remove any found and return all affected product immediately. The PI-128 is also a component of the System One Comprehensive Lap CBDE Kist, catalog number 50000, which is a convenience kit. The customer is being instructed to remove the PI-128, Intraducer Peritoneal Catheter contained in the System Once Comprehensive Lap CBDE Kit in the eight kit lots listed, and return the PI-128 catheters. All other components of the kit may be used. As the PI-128, Intraducer Peritoneal Catheter, can also be ordered as a replacement component, the customer is also being instructed to check all opened System One Comprehensive lap CBDE kits, regardless of lot number, to ensure that it does not contain the impacted PI-128 lots. The customers were requested to complete and return the enclosed Acknowledgment & Stock Status Form, which includes an option to obtain replacement product for the PI-128, immediately faxing it back to Linda Todd at 919-433-4986. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Root cause

Other

Status

Terminated

Product code

GBW

Quantity affected

5,769 catheters

Distribution

Worldwide, including USA, Guam, Australia, Iceland and Italy

Date initiated

2007-01-19

Date posted

2007-02-15

Date terminated

2009-08-12

Location

Geneva, IL

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