FDA Medical Device Recalls (openFDA)
Opti Medical Systems Inc: Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l
- Recall number
- Z-2152-2008
- Recalling firm
- Opti Medical Systems Inc
- Product
- Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l,
- Status
- Terminated
- Initiated
- 2008-05-08
- Posted
- 2008-08-14
- Terminated
- 2010-01-22
- Reason
- This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.
- Root cause
- Nonconforming Material/Component
- Action
- Opti Medical sent a Recall Notice, dated May 8, 2008 to all consignees. Consignees were notified via email on/about May 5th thru 7th , 2008. They were instructed to discontinue use of the affected lot and to immediately return all remaining product to OPTI Medical for replacement.
- Quantity
- 31750 tubes
- Distribution
- Worldwide Distribution: USA, Puerto Rico, Austria, China, Chile, Cyprus, Great Britain, Japan, Netherlands, and Senegal
- Lot, serial or model codes
- Part #MC0024, Lot #1112254
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GIO
- Firm FEI
- 3004102403
- Firm city
- Roswell
- Firm state
- GA
- 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