Atlas FDA

AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803

FDA device recall Z-0711-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm
Enpath Medical, Inc.
Reason for recall
The product is labeled as sterile product but had not been sterilized.
Action taken
The only direct consignee, to whom the product was shipped, was notified of the recall by telephone and fax on February 26, 2004. The consignee was requested to the return the product and to sub-recall the product from their customers.
Root cause
Other
Status
Terminated
Product code
GAA
Quantity affected
20 ten-pack kits
Distribution
All of the product was shipped to a distributor in New York.
Date initiated
2004-02-26
Date posted
2004-07-20
Date terminated
2006-06-25
Location
Plymouth, MN

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.