Catheter recalled over mold contamination
- Recall date
- February 17, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Arrow International Inc recalls Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
- Recall number
- Z-2771-2016
- FDA classification
- Class II
- Brand / firm
- Arrow International Inc
- Sold / distributed
- US Distribution to states of: NC, OH, FL, and MD.
Why it was recalled
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
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