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Terminated

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

FDA Recall Z-0711-04 · Posted 2004-07-20

Recalling FirmEnpath Medical, Inc.
Recall StatusTerminated
Product CodeGAA
Date Initiated2004-02-26
Date Terminated2006-06-25
Product Quantity20 ten-pack kits

Reason for Recall

The product is labeled as sterile product but had not been sterilized.

Firm Action

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

Distribution Pattern

All of the product was shipped to a distributor in New York.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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