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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 Device Recall Taut Intraducer Peritoneal Cathetersee related information
Date Initiated by FirmJanuary 19, 2007
Date PostedFebruary 15, 2007
Recall Status1 Terminated 3 on August 12, 2009
Recall NumberZ-0428-2007
Recall Event ID 37182
510(K)NumberK960883 
Product Classification Peritoneal Catheter - Product Code GBW
ProductTaut 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 IL 60134-2505
For Additional Information ContactMs. 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		Other
ActionTaut 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 Commerce5,769 catheters
DistributionWorldwide, including USA, Guam, Australia, Iceland and Italy
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GBW
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