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FDA Medical Device Recalls (openFDA)

Drummond Scientific Co: Separation Technology ClearCRIT Capillary Tubes 75mm/1.1mm ID. Catalog number 270-106. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.

Recall number
Z-0211-2009
Recalling firm
Drummond Scientific Co
Product
Separation Technology ClearCRIT Capillary Tubes 75mm/1.1mm ID. Catalog number 270-106. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714. 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
12,000 vials
Distribution
Nationwide Distribution --- including states of FL and MA.
Lot, serial or model codes
Lot numbers 0715, 1158, 1428, and 1898
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

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