Recall Z-1252-2012 ยท KYZ Syringe, Irrigating (Non Dental)
Customed, Inc
Irrigation Tray w/Bulb syringe, catalog# 900-020
| Date | Mar 21, 2012 (initiated Dec 8, 2011) |
| Status | Terminated |
| Reason | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
| Root cause | Packaging |
| Action | Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions: 1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used. 2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products. 3. If products has been futher distributed, sub-recall produc |
| Quantity | 0 |
| Distribution | USA Nationwide Distribution - including Florida and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924809 | IRRIGATION TRAY W/ BULB SYRINGE Customed, Inc., Jun 7, 1993 |