FDA Medical Device Recalls (openFDA)
Drummond Scientific Co: Iris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
- Recall number
- Z-0208-2009
- Recalling firm
- Drummond Scientific Co
- Product
- Iris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
- Status
- Terminated
- Initiated
- 2008-08-01
- Posted
- 2008-11-07
- Terminated
- 2008-12-18
- Reason
- presence of OSCS contaminant
- Root cause
- Material/Component Contamination
- Action
- The recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.
- Quantity
- 2000 vials
- Distribution
- Nationwide Distribution --- including states of FL and MA.
- Lot, serial or model codes
- Catalog number 59-002828-001 A - Lot numbers 8129 exp 6/10 and Lot number 8169 exp 7/10 and Catalog number 59-000857-002 G - Lot number 8200 exp 9/10.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GIO
- Firm FEI
- 2518153
- Firm city
- Broomall
- Firm state
- PA
- 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