FDA Device recall Z-0354-2023
Alcon Custom Pak Surgical Procedure Pack
- FDA Device
- Class II
- ongoing
- Published 2022-12-07
On 2022-12-07 the FDA classified a Class II recall of Alcon Custom Pak Surgical Procedure Pack by Alcon Research, citing due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0354-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-31 |
| Published | 2022-12-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alcon Research |
| Distribution | US |
Product
Alcon Custom Pak Surgical Procedure Pack
Reason
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.
Identifiers
| code_info | UDI Codes for: UDI for Latex Free Custom Pak: H5301ALCON1CPAK10B UDI for Latex Free Custom Pak: H5302ALCON2CPAK20E C…UDI Codes for: UDI for Latex Free Custom Pak: H5301ALCON1CPAK10B UDI for Latex Free Custom Pak: H5302ALCON2CPAK20E Custom Pak # / Lot #: Custom Pak # Lot # 100007214 14ACYR 100007214 14C8KP 100007214 14CFP3 100011843 149HV5 100011843 150DMH 100012716 150CX9 100060730 2538660H 100060730 2540367H 100060730 14UWK4 100060730 14XTYA 100060730 14YHL2 100060730 150LWW 100064778 14DEM2 100064778 14FY9L 100064778 14NFK2 100064778 14TX0N 100064778 14TX0V 100064778 JZ5141146 100064778 14X73C 100072572 149WDA 100072572 149YF1 100072572 14C6LE 100082908 JZ5120745 100082908 JZ5121811 100082908 JZ5123118 100082908 JZ5123538 100082908 JZ5125017 100082908 JZ5126725 100082908 JZ5141666 100083383 JZ5125990 100083383 JZ5125085 100083383 JZ5128291 100083383 JZ5128981 100083383 JZ5137217 100083383 JZ5141156 100083383 JZ5145948 100087432 14WRAH 100104358 JZ5085044 100104358 JZ5094040 100104358 JZ5093549 100104358 JZ5096554 100104358 JZ5105416 100104358 JZ5112098 100104358 JZ5122222 100104358 JZ5123117 100 |
|---|
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-0354-2023%22
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