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RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY… recallZ-1359-2011 · Arrow International Inc · initiated Oct 29, 2010

Terminated All recalls posted in February 2011

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

Sterility may be compromised.

FDA root cause category: Other

What the company is doing

Arrow International, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated October 29, 2010, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customer. Customers were instructed to quarantine the product. If they had no affected product in stock, check the appropriate box on the Recall Acknowledgement & Stock Status Form and fax the form to Arrow's Customer Service fax number 800-343-2935. If they had affected stock, immediately quarantine the product and contact Arrow Customer Service at 800-523-8446 for a Return Authorization Number. If customers wished to return product for replacement, they were to consult their sales representative or Arrow Customer Service for information on product availability, substitutability, and lead times. Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the compoleted form to Arrow, Fax number 800-343-2935, Attn: Customer Service. Return any affected product freight collect, along with the original completed Recall Acknowledgement & Stock Status Form to: Arrow International, Inc. 312 Commerce Place Aheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. For any questions regarding this recall call 800-523-8446.

Recall details

Recall number
Z-1359-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 29, 2010
Posted by the FDA
Feb 17, 2011
Recalling firm
Arrow International Inc
Quantity
8,560 units
Product code
DQX
FDA submissions
K810675
Distribution
Worldwide Distribution -- United States - all 50 States, and the countries of Canada, South America, China, South Africa, Australia, Puerto Rico, Philippines, Singapore, South Korea, New Zealand, Mexico, Japan, India, Indonesia, Bahamas, Taiwan, Thailand, Finland, France, Cyprus, Czech Republic, Belgium, Germany, Ireland, Italy, Latvia, Netherlands, Poland, Slovakia, Spain, Bahamas, Costa Rico, Dominican Republic, Ecuador, Guatamala and the United Kingdom.

Product description

RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY FEATURES/Product SKU (Code) HF-04020-1. Cardiovascular catheter wire guide

Code information (models, lots, serial numbers)

Lot Numbers: RF0017630, RF0021276, RF0047810, RF0075670, RF8045172, RF8045506, RF8056833, RF8069627, RF8071319, RF8110927, RF9015802, RF9030635, RF9056019, RF9068611, RF9071050, RF9086007, RF9097842, RF9100852 and RF9114874.

Other devices under the same FDA submission

117 devices cleared under K810675 — 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 57287).

Sources and updates

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