Taut, Inc. Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; Taut Inc., 2561 Kaneville Ct., Geneva, IL 60134; the individually packaged, sterilirzed catheter was sold in two configurations: a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; Taut Inc., 2561 Kaneville Ct., Geneva, IL 60134; the individually packaged, sterilirzed catheter was sold in two configurations: a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit
Brand
Taut, Inc.
Lot Codes / Batch Numbers
catalog number (REF) PI-128, lot number 04116, use by 2008-01, and lot number 05178, kit lot numbers KC05107, KC05186, KC06002, KC06025, KC06071, KC06060, KC06087, KC06116
Products Sold
catalog number (REF) PI-128, lot number 04116, use by 2008-01, and lot number 05178, use by 2008-09 These two lots of catheters were sold individually and as sterile components of catalog number (REF) 50000, kit lot numbers KC05107, KC05186, KC06002, KC06025, KC06071, KC06060, KC06087, KC06116
Taut, Inc. is recalling Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for due to Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026