Skip to content

i-STAT EG7+ Cartridge recallZ-1540-2009 · Abbott Point of Care Inc. · initiated Feb 23, 2009

Terminated All recalls posted in June 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Point of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-1540-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 23, 2009
Posted by the FDA
Jun 18, 2009
Recalling firm
Abbott Point of Care Inc.
Quantity
1048 boxes of 25 cartridges each.
Product code
CHL
FDA submissions
K894914, K912387, K934642, K940918
Distribution
Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.

Product description

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

6 devices cleared under K894914, K912387, K934642, K940918 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 51211).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page