Recalls / —

—#95794

Product

EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) ASK-03001-KC, ASK-03001-KC1 and HH-03000. Epidural anesthesia kit

FDA product code

CAZ — Anesthesia Conduction Kit

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K770356

Affected lot / code info

ASK-03001-KC Lot Numbers: RL8067536 and RL8088127.  ASK-03001-KC1 Lot Numbers: RF0019736 and RL8128948.  HH-03000 Lot Numbers: RF0034516, RF0076550, RF8045507, RF8069628, RF8072014, RF8085134, RF8096832, RF8119796, RF9031152, RF9057640, RF9070896, RF9073140, RF9112779 and RF9126209.

Why it was recalled

Sterility may be compromised.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2010-10-29

Posted by FDA

2011-02-17

Terminated

2012-09-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #95794. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.