Recall Z-1368-2018 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Teleflex Medical Europe Ltd
Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.
| Date | Apr 12, 2018 (initiated Mar 15, 2018) |
| Status | Terminated |
| Reason | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Root cause | Employee error |
| Action | The firm initiated their field correction on 03/15/2018 by letter. The notices stated the following: Affected distributors are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgment form, communicate this notification to any of your customers who have received product included within the scope of this notification. 3. Have each of your customers who received the affected product return a completed acknowledgment form to you. 4. Once you have |
| Quantity | 6340 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962472 | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER Rusch Intl., Aug 27, 1996 |