Product Safety Recalls

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Trinity Sterile, Inc. Recall 90625

Description: Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

Trinity Sterile, Inc. Recall 90625 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1551-2022
Event ID90625
Event DescriptionWolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
Product TypeDevices
DistributionUS Nationwide distribution in the states of FL, PA.
Quantity4,169 cases (125,070 eaches)
Recall ReasonKits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Device Classification20220824
Device Code InfoUDI-DI: 10850007185722 Case 00850007185725 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012 600013 600014 600015 600017 600018 600019
Center Classification Date20220818
Recall Initiation Date20220629
Recalling FirmTrinity Sterile, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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