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Super Arrow-Flex(R) PSI Set recallZ-0936-2011 · Arrow International Inc · initiated Dec 20, 2010

Terminated All recalls posted in January 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

Packaging may have been compromised, and sterility of product cannot be guaranteed.

FDA root cause category: Other

What the company is doing

The firm, Teleflex Medical thru its subsidiary Arrow International, Inc., sent an "Urgent Field Safety Notice" letter dated December 20, 2010, with Field Acknowledgement form to all customers. The letter described the product, problem and action to be taken by the customers. The letter instructed the customers to check their stock for affected product, cease use and distribution of product and quarantine all products from affected lot immediately; contact their local Teleflex Medical Customer Service/Sales Rep (or Distributor) for a return authorization number prior to filling out the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM; and complete and return the form immediately by email. If you do not have the product from the affected lot, indicate it on the form and fax it to your local Teleflex Medical Customer Service/Sales Rep (or Distributor). The Teleflex Medical Customer Service/Sales Rep (or Distributor) will coordinate the product return with the customer. If you have any questions, please contact the Regulatory Affairs Project Manager at 610-378-0131 ext 3318 or email: [email protected].

Recall details

Recall number
Z-0936-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 20, 2010
Posted by the FDA
Jan 21, 2011
Recalling firm
Arrow International Inc
Quantity
320 units
Product code
DYB
FDA submissions
K780532
Distribution
International distribution only: countries include: Austria, Belgium, Czech Republic, Germany, Greece, Italy, and Luxembourg.

Product description

Super Arrow-Flex(R) PSI Set Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures

Code information (models, lots, serial numbers)

Part No: CL-07645, Lot No: CF0014630

Other devices under the same FDA submission

46 devices cleared under K780532 — 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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