Recall Z-0490-2025 ยท OJK Eye Tray
Alcon Research LLC
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CT
| Date | Nov 19, 2024 (initiated Oct 15, 2024) |
| Status | Open, Classified |
| Reason | Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. |
| Root cause | Use error |
| Action | Alcon issued a letter dated October 16, 2024 "COMMUNICATION OF MEDICAL DEVICE CORRECTION FROM CARDINAL HEALTH" (ALCON CUSTOM PAK COMPONENT SUPPLIER) regarding Alcon Custom Pak surgical kits which contain Cardinal Health Salem Sump PVC Tubes - Double Lumen Nasogastric (NG) Tube. Alcon is instructing its customers to: (1) Read the attached Cardinal Health Medical Device Correction notice. Cardinal Health recommends customers review the eIFU and updated product labels. (2) Complete the attached Alcon Customer Response Form. (3) Return the Alcon Customer Response Form by Fax: 817-302-4337 Emai |
| Quantity | 3486 surgical kits |
| Distribution | US distribution to states of: Delaware, Illinois, and Oklahoma |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.