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10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set recallZ-0088-04 · Arrow International Inc · initiated Oct 22, 2003

Terminated All recalls posted in November 2003

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 Arrow International 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

package lid identifies the contents incorrectly

FDA root cause category: Other

What the company is doing

The recalling firm notified the consignees via telephone on 10/22/03 regarding the problem and the need to return the product.

Recall details

Recall number
Z-0088-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 22, 2003
Posted by the FDA
Nov 1, 2003
Recalling firm
Arrow International Inc
Quantity
80 units
Product code
KZH
FDA submissions
K924607
Distribution
The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka

Product description

10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set

Code information (models, lots, serial numbers)

Catalog/Model number CL-07011, Lot number CF03075226

Other devices under the same FDA submission

12 devices cleared under K924607 — 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

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