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Martel Printer Accessory to i-STAT Portable Clinical… recallZ-2328-2009 · Abbott Point of Care Inc. · initiated Apr 22, 2009

Terminated All recalls posted in September 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

It appears that the rechargeable battery pack is overheating with or without the presence of smoke.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Urgent Recall Notice letters dated April 2009 were sent out the third week of April by Federal Express. The letter discussed the background, required actions, and additional information. Customers are to identify all affected Martel printer rechargeable battery packs, record the number of affected packs on the attached business reply cards, and return the card along with the affected batteries as instructed. Questions should be directed to Abbott Technical Support at 800-366-8020.

Recall details

Recall number
Z-2328-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 22, 2009
Posted by the FDA
Sep 30, 2009
Recalling firm
Abbott Point of Care Inc.
Quantity
2552
Product code
CGA
FDA submissions
K001387
Distribution
Worldwide Distribution

Product description

Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.

Code information (models, lots, serial numbers)

Printer i-STAT Catalog number 06723-91; battery pack catalog number 06F21-35. Martel Printers with serial numbers 281071578 to 281071977; 281174571 to 281174970; 281276302 to 281276701 and 290178290 to 290178689. Repaired printers received since November 4, 2008; Replacement chargeable battery packs received since October 30, 2008.

Other devices under the same FDA submission

7 devices cleared under K001387 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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