FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313
- Recall number
- Z-1078-04
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313
- Status
- Terminated
- Initiated
- 2004-06-29
- Posted
- 2004-07-20
- Terminated
- 2006-05-02
- Reason
- Sterility of product is not assured
- Root cause
- Other
- Action
- Smiths Medical notified consignees by telephone on June 29, 2004. The consignees were asked to immediately quarantine their stock . The Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004.
- Quantity
- 180 CASES (400/CS)
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number: K527299
- 510(k) numbers
- ["K011925"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- 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