Recall Z-2266-2019 ยท GBX Catheter, Irrigation
Degania Silicone, Ltd.
Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
| Date | Jun 28, 2019 |
| Status | Terminated |
| Reason | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body |
| Root cause | Process control |
| Action | Degania Silicone Ltd. notified accounts by letter dated June 28, 2019 describing the problem, health risk and action to take: Please forward this information to the immediate attention of the persons responsible for usage of the affected parts. Sub-recall must be initiated by your company to collect any distributed product from the suspected list.2. Please fill in the attached Recall Response form and indicate the quantity of the affected product in your possession. 3. Promptly return the completed Recall Response form to Degania Silicone by e-mail: kkayam@qco.net. 4. Disposition of the recall |
| Quantity | 200 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.