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Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, RE

FDA device recall Z-0779-2020 · posted 2020-01-06 · Terminated

Recall details

Recalling firm
Medical Action Industries, Inc. 306
Reason for recall
The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.
Action taken
The firm initiated the recall by letter on 12/03/2019. The firm requested distributors apply stickers to the all affected kits in inventory and further notify their customers with a separate letter. End users are requested to discard the affected product.
Root cause
Other
Status
Terminated
Product code
KDD
Quantity affected
9924 cases
Distribution
MA, RI, PA, MD, VA, NC, SC, GA, FL, KY, OH, IN, MI, IL, MO, NE, LA, TX, AZ, CA, WA
Date initiated
2019-12-02
Date posted
2020-01-06
Date terminated
2023-01-24
Location
Arden, NC

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