TheraCath(R) Epidural Catheter recall: Sterility Concern
TheraCath(R) Epidural Catheter; Product Code: EC-05000
Why was TheraCath(R) Epidural Catheter recalled?
Product sterility may be compromised due to unsealed packaging.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 13F17B0147 13F17C0176 13F17C0419 13F17E0464 13F17F0039 13F17F0498 13F17F0609 13F17F0789 13F17G0250 13F17J0076 13F17K0413 13F17K0414 13F17K0415 13F17K0416
- Product
- TheraCath(R) Epidural Catheter; Product Code: EC-05000
- Recalling firm
- Arrow International Inc
- Quantity
- 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
- Recall date
- June 6, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)