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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