Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Reported: May 19, 2021 Initiated: April 9, 2021 #Z-1557-2021
Product Description
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Reason for Recall
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Details
- Recalling Firm
- Medical Action Industries, Inc. 306
- Units Affected
- 10 cases (20 kits per case)
- Distribution
- Distributed US nationwide to OH, OR, FL and CA.
- Location
- Arden, NC
Frequently Asked Questions
What product was recalled? ▼
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B. Recalled by Medical Action Industries, Inc. 306. Units affected: 10 cases (20 kits per case).
Why was this product recalled? ▼
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 19, 2021. Severity: Critical. Recall number: Z-1557-2021.
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