Atlas FDA

Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Indu

FDA device recall Z-1953-2014 · posted 2014-07-01 · Terminated

Recall details

Recalling firm
Medical Action Industries Inc
Reason for recall
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Action taken
Consignees were notified via E-Mails, Certified Letters and Telephone on 06/12/2014.
Root cause
Nonconforming Material/Component
Status
Terminated
Product code
OVN
Quantity affected
474 cs (9,480 ea) total for all kits involved
Distribution
Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
Date initiated
2014-06-12
Date posted
2014-07-01
Date terminated
2015-02-03
Location
Arden, NC

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