Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea… recallZ-0370-2008 · Abbott Point of Care Inc. · initiated Oct 18, 2007

Why it was recalled

Difficult to Close -- Certian lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

FDA root cause category: Packaging change control

What the company is doing

Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.

Recall details

Recall number

Z-0370-2008

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Oct 18, 2007

Posted by the FDA

Dec 11, 2007

Recalling firm

Abbott Point of Care Inc.

Product code

JGS

FDA submissions

K001154, K912387

Distribution

Worldwide Distribution- including USA and country of Canada.

Product description

Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01; Part No: 121000; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.

Other devices under the same FDA submission

1 device cleared under K001154, K912387 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• i-STAT 03P80-25

  Abbott Point Of Care Inc. · ELECTRODE, ION SPECIFIC, SODIUM
  9 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 44972).

• Z-0371-2008 · Terminated
  Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
• Z-0372-2008 · Terminated
  Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No: 121500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
• Z-0373-2008 · Terminated
  Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No: 320100; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
• Z-0374-2008 · Terminated
  Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product…
• Z-0375-2008 · Terminated
  Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No: 120100; Abbott Point of Care, Inc., East Windsor, NJ 08520, USA; Product of Canada.