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U.S. Department of Health and Human Services

Class 2 Device Recall Taut Intraducer Peritoneal Catheter

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 Class 2 Recall
Taut Intraducer Peritoneal Catheter
see related information
Date Posted February 15, 2007
Recall Status1 Terminated on August 12, 2009
Recall Number Z-0428-2007
Recall Event ID 37182
Premarket Notification
510(K) Number
K960883 
Product Classification Catheter, Peritoneal - Product Code GBW
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
Code Information 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
Recalling Firm/
Manufacturer
Taut, Inc.
2571 Kaneville Ct
Geneva, Illinois 60134-2505
For Additional Information Contact Ms. Julie McDowell
610-948-2836
Manufacturer Reason
for Recall
Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action 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.
Quantity in Commerce 5,769 catheters
Distribution Worldwide, including USA, Guam, Australia, Iceland and Italy
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GBW and Original Applicant = TAUT, INC.
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