Recall Z-0113-2018 ยท BSY Catheters, Suction, Tracheobronchial
Medline Industries Inc
MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
| Date | Nov 18, 2017 (initiated Oct 10, 2017) |
| Status | Terminated |
| Reason | Products labeled as sterile were distributed prior to sterilization |
| Root cause | Employee error |
| Action | The recall was initiated by mail on 10/10/2017. The letter contained the following directive: "REQUIRED ACTION: 1. Immediately check your stock for item numbers DYNCPE8 (Lot 2861707008) & DYNCSDS12 (Lot 28617070015) place them on hold and complete the attached response form. Quarantine all affected product / lots. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. When we receive your completed response form you w |
| Quantity | 120 units |
| Distribution | FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.