Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
Reported: May 16, 2018 Initiated: February 28, 2018 #Z-1638-2018
Product Description
Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
Reason for Recall
Potential friction holes may affect the sterility of the product.
Details
- Recalling Firm
- Vygon U.S.A.
- Units Affected
- 16,520 total products
- Distribution
- Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
- Location
- Lansdale, PA
Frequently Asked Questions
What product was recalled? ▼
Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.. Recalled by Vygon U.S.A.. Units affected: 16,520 total products.
Why was this product recalled? ▼
Potential friction holes may affect the sterility of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1638-2018.
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