Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone catheter tube assembly, 3-1 Liter coll
FDA device recall Z-0618-2009 · posted 2008-12-30 · Terminated
Recall details
- Recalling firm
- ConvaTec
- Reason for recall
- It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.
- Action taken
- 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 reinforce the importance of proper lubrication and following the directions. A return form is to be completed by ConvaTec reps for each visit indicating the name of the Health Care Provider and that the they personally received notice of the product correction. All remaining sample products are to be returned to Besta, Franklin, WI.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 795
- Distribution
- Worldwide Distribution --- including USA and country of Canada.
- Date initiated
- 2008-11-20
- Date posted
- 2008-12-30
- Date terminated
- 2009-03-09
- Location
- Skillman, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONVATEC FECAL MANAGEMENT SYSTEM (K032734) | Convatec, A Bristol-Myers Squibb Co. | 2004-04-08 |