FDA Medical Device Recalls (openFDA)
Enpath Medical, Inc.: AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803
- Recall number
- Z-0711-04
- Recalling firm
- Enpath Medical, Inc.
- Product
- AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803
- Status
- Terminated
- Initiated
- 2004-02-26
- Posted
- 2004-07-20
- Terminated
- 2006-06-25
- Reason
- The product is labeled as sterile product but had not been sterilized.
- Root cause
- Other
- 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.
- Quantity
- 20 ten-pack kits
- Distribution
- All of the product was shipped to a distributor in New York.
- Lot, serial or model codes
- Lot W24005, Use By 2005-03
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAA
- Firm FEI
- 2183787
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28