FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: 4904 Glass L.O.R. Syringe
- Recall number
- Z-0244-06
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- 4904 Glass L.O.R. Syringe
- Status
- Terminated
- Initiated
- 2005-11-17
- Posted
- 2005-11-30
- Terminated
- 2012-05-08
- Reason
- Tray may contain holes compromising the sterility of the device
- Root cause
- Other
- Action
- Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 102518, K163468, K176555, K510385, K520203, K529939, K532723, K533729, K586882, K633942, K675421, K676747, K681955, K682698
- 510(k) numbers
- ["K965017"]
- PMA numbers
- not on file
- Product code
- CAZ
- 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