Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Reported: September 21, 2016 Initiated: February 17, 2016 #Z-2771-2016
Product Description
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Reason for Recall
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 6,121 units in total
- Distribution
- US Distribution to states of: NC, OH, FL, and MD.
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components. Recalled by Arrow International Inc. Units affected: 6,121 units in total.
Why was this product recalled? ▼
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2016. Severity: Moderate. Recall number: Z-2771-2016.
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