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Terminated

CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266

FDA Recall Z-2459-2015 · Posted 2015-08-25

Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeMED
Date Initiated2015-07-27
Date Terminated2016-07-06
Product Quantity23,426 cases

Reason for Recall

Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.

Firm Action

A Urgent Product Notification Letter dated July 27, 2015, will be sent to customers and distributor who purchased the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24 month shelf life. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the requested information on the enclosed postage paid Business Reply Card and return it to Stericycle. Customers with questions or need additional packing labels are instructed to contact Stericycle at (877) 550-0701, M-F, 8am-5pm ET. Customers are instructed to report complaints or suspected problems with CIDEX Activated Dialdehyde Solution by contacting (888) 783-7723.

Root Cause

Device Design

Distribution Pattern

US (nationwide) Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060618CIDEX ACTIVATED DIALDEHYDE SOLUTIONJohnson & Johnson Co. · 2006-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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