FDA Medical Device Recalls (openFDA)
Abbott Point of Care Inc.: i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc., Abbott Park, IL 60064 USA Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.
- Recall number
- Z-1540-2009
- Recalling firm
- Abbott Point of Care Inc.
- Product
- i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc., Abbott Park, IL 60064 USA Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.
- Status
- Terminated
- Initiated
- 2009-02-23
- Posted
- 2009-06-18
- Terminated
- 2009-07-29
- Reason
- Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
- Root cause
- Packaging process control
- Action
- Urgent Recall Notice letters pertaining to the EG7+ Cartridges were sent on February 23, 2009 by first class mail to all customers. The firm found one other affected lot of G3+ cartridges and expanded the recall to include one other lot. Letters for the expansion are dated May 2009. Customers were asked to use the attached form to record all of the box numbers if they have any cartridges from the affected lot. Cartridges from the box numbers listed will be replaced an any remaining unused cartridges from those specific boxes are to be returned as instructed on the form. To receive replacement cartridges, customers are to follow the instructions on the enclosed customer reply form. If any cartridges from the affected lot were forwarded to another facility, a copy of the recall letter needs to be provided to them and the information at the bottom of the customer reply form should be completed. Questions should be directed to 1-800-366-8020, Option 1.
- Quantity
- 1048 boxes of 25 cartridges each.
- Distribution
- Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.
- Lot, serial or model codes
- Lot number P08274A, Box numbers: 0822, 0823, 0824, 0831, 0832, 0833, 0834, 0841, 0842, 0843, 0844, 0851, 0852, 0853, 0854, 0861, 0862, 0863, 0864, 0871, 0872, 0873, and 0874.
- 510(k) numbers
- ["K894914","K912387","K934642","K940918"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 2245578
- Firm city
- East Windsor
- Firm state
- NJ
- 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