Recall Z-0428-2007 ยท GBW Catheter, Peritoneal
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 co
| Date | Feb 15, 2007 (initiated Jan 19, 2007) |
| Status | Terminated |
| Reason | Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters. |
| Root cause | Other |
| 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 |
| Quantity | 5,769 catheters |
| Distribution | Worldwide, including USA, Guam, Australia, Iceland and Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960883 | INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 Taut, Inc., Mar 20, 1996 |