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Arrow central venous catheterization kit, 14 ga x 20 cm recallZ-0083-04 · Arrow International Inc · initiated Sep 16, 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

wrong product in box

FDA root cause category: Other

What the company is doing

The recalling firm issued a recall letter to their direct customers dated 9/16/03. The recall letter explained the reason for recall and to return the product.

Recall details

Recall number
Z-0083-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 16, 2003
Posted by the FDA
Nov 1, 2003
Recalling firm
Arrow International Inc
Quantity
240 units
Product code
KZH
FDA submissions
K862056
Distribution
The products were shipped to distributors in AL, AZ, CA, CO, FL, HI, IL, IN, KS, MD, MI, MN, MO, NC, NM, NY, OH, PA, TN, TX, VA, and WI. The products were shipped to government accounts in AZ, AK, DC, IN, SC, and VA. The products were shipped to hospitals nationwide.

Product description

Arrow central venous catheterization kit, 14 ga x 20 cm

Code information (models, lots, serial numbers)

Catalog number AK-04700, Lot number RF3067086

Other devices under the same FDA submission

132 devices cleared under K862056 — 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 27415).

Sources and updates

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