TheraCath(R) Epidural Catheter; Product Code: EC-05000
Reported: June 6, 2018 Initiated: April 11, 2018 #Z-2012-2018
Product Description
TheraCath(R) Epidural Catheter; Product Code: EC-05000
Reason for Recall
Product sterility may be compromised due to unsealed packaging.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 416,055 total products
- 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
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
TheraCath(R) Epidural Catheter; Product Code: EC-05000. Recalled by Arrow International Inc. Units affected: 416,055 total products.
Why was this product recalled? ▼
Product sterility may be compromised due to unsealed packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 6, 2018. Severity: Moderate. Recall number: Z-2012-2018.
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