FDA Enforcement
Class II
Terminated
VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
Recall: Z-2027-2018
·
Reported June 6, 2018
Enforcement
- Recall Number
- Z-2027-2018
- Event ID
- 79890
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 6, 2018
- Initiation Date
- April 11, 2018
- Classification Date
- May 30, 2018
- Termination Date
- May 15, 2020
- Address
- 2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States
Description
VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
Reason
Product sterility may be compromised due to unsealed packaging.
Code Info
Lot Numbers: 13F17A0288
Distribution
US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
Quantity
416,055 total products