FDA Device recall Z-2407-2023
Centurion FMS Pak
- FDA Device
- Class II
- ongoing
- Published 2023-08-23
On 2023-08-23 the FDA classified a Class II recall of Centurion FMS Pak by Alcon Research, citing reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2407-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-28 |
| Published | 2023-08-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alcon Research |
| Distribution | US |
Product
Centurion FMS Pak
Reason
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Identifiers
| code_info | Catalog No. 8065000133, 8065000134, 8065000138, 8065000139, 8065752192, 8065752193, 8065752200, 8065752201, 8065752202,…Catalog No. 8065000133, 8065000134, 8065000138, 8065000139, 8065752192, 8065752193, 8065752200, 8065752201, 8065752202, 8065752203, 8065752216, 8065752217, 8065752245, 8065752917, 8065752918, 8065753134, 8065753135, 8065753136, 8065753159; Product Code 100241014, 100241015, 100241019, 100241020, 100055107, 100055110, 100009955, 100009963, 100009964, 100009965, 100009960, 100009961, 100010766, 100056645, 100055945, 100207171, 100207170, 100208838, 100208338; UDI-DI: 380650001337, 380650001344, 380650001382, 380650001399, 380657521920, 380657521937, 380657522002, 380657522019, 380657522026, 380657522033, 380657522163, 380657522170, 380657522453, 380657529179, 380657529186, 380657531349, 380657531356, 380657531363, 380657531592; Lots 14WW1F, 14WW1H, 14WW1J, 14X6CN, 14X6CP, 14X6CR, 14X6CT, 14X6CU, 14X6CV, 14XPE9, 14XPEA, 14XPEC, 14XPED, 14XPEE, 14XPEF, 14XPEH, 14Y8C2, 14Y8C3, 14Y8C4, 14Y8C5, 14Y8C6, 14Y8C7, 14YLMF, 14YLMH, 14YLMJ, 14YLMK, 14YLML, 14YLMM, 14YLMN, 14YLMP, 14YXHY, 14YXJ0, 14Y |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2407-2023%22
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