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Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of ...

FDA Device Recall #Z-1636-2018 — Class II — February 28, 2018

Recall Summary

Recall Number Z-1636-2018
Classification Class II — Moderate risk
Date Initiated February 28, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Vygon U.S.A.
Location Lansdale, PA
Product Type Devices
Quantity 16520 total products

Product Description

Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.

Reason for Recall

Potential friction holes may affect the sterility of the product.

Distribution Pattern

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Lot / Code Information

Lot Numbers: 17F001D & 17K038D UDI: 08498840004814

Other Recalls from Vygon U.S.A.

Recall # Classification Product Date
Z-1689-2021 Class II Vygon Dressing Change w/ Maxiswab - Product Usa... Apr 15, 2021
Z-1114-2019 Class II Vygon DUALSTOP Red Cap used for intravascular l... Dec 6, 2018
Z-1115-2019 Class II Vyon DUALSTOP White Cap used for intravascular ... Dec 6, 2018
Z-1637-2018 Class II PICC Tray, Product Code: AMS-9093CP Conveni... Feb 28, 2018
Z-1640-2018 Class II PICC Insertion Tray, Product Code: AMS-7192CS-4... Feb 28, 2018

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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