Reported Dec 7, 2022 · Ongoing
Alcon Custom Pak Surgical Procedure Pack
Alcon Research, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research, LLC · 9965 Buffalo Speedway · Houston, TX · 77054-1309
Is this the product you have?
- Alcon Custom Pak Surgical Procedure Pack
- Lot codes and dates
- UDI Codes forUDI
- for Latex Free Custom PakH5301ALCON1CPAK10B
- UDI for Latex Free Custom PakH5302ALCON2CPAK20E Custom Pak # / Lot #: Custom Pak # Lot #
3,567 of 3,567 codes
10000721414ACYR10000721414C8KP10000721414CFP3100011843149HV5100011843150DMH100012716150CX91000607302538660H1000607302540367H10006073014UWK410006073014XTYA10006073014YHL2100060730150LWW10006477814DEM210006477814FY9L10006477814NFK210006477814TX0N10006477814TX0V100064778JZ514114610006477814X73C100072572149WDA100072572149YF110007257214C6LE100082908JZ5120745100082908JZ5121811100082908JZ5123118100082908JZ5123538100082908JZ5125017100082908JZ5126725100082908JZ5141666100083383JZ5125990
- Amount recalled
- 308,610 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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