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Easypump ST 100-1 infusion pump recallZ-0584-06 · I-Flow Corporation · initiated Jan 17, 2006

Terminated All recalls posted in March 2006

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 I-Flow Corporation 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

The sterile pack may contain the wrong infusion pump inside.

FDA root cause category: Other

What the company is doing

The affected customer has been notified with a Notification letter dated January 17, 2006 via e-mail of Recall Notification Letter, with follow-up confirmation e-mails.

Recall details

Recall number
Z-0584-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 17, 2006
Posted by the FDA
Mar 7, 2006
Recalling firm
I-Flow Corporation
Quantity
630
Product code
MEB
FDA submissions
K052117, K932740
Distribution
France only

Product description

Easypump ST 100-1 infusion pump

Code information (models, lots, serial numbers)

lot 562791

Other devices under the same FDA submission

31 devices cleared under K052117, K932740 — 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 34494).

Sources and updates

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