Recall Z-0618-2009 ยท KNT Tubes, Gastrointestinal (And Accessories)
ConvaTec
Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104 ConvaTec Skillman, NJ Made in USA with imported components "For the fecal management of patients with little or no bowel control and liquid or semi-liquid stool."
| Date | Dec 30, 2008 (initiated Nov 20, 2008) |
| Status | Terminated |
| Reason | It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Product Correction Letters were sent by first class mail on November 18, 2008 to Healthcare Professionals and ConvaTec Reps. The reason for the recall was identified along with possible risk to patient. Healthcare professionals were asked to use sufficient lubricating jelly during the insertion process with special care given to those who have a tendency to bleed or are on anti-coagulant medication. Physician should be notified if rectal bleeding or abdominal symptoms develop. ConvaTec reps were asked to contact all health care professionals to whom product or samples were given and r |
| Quantity | 795 |
| Distribution | Worldwide Distribution --- including USA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032734 | CONVATEC FECAL MANAGEMENT SYSTEM Convatec, A Bristol-Myers Squibb Co., Apr 8, 2004 |