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U.S. Department of Health and Human Services

Class 2 Device Recall SINGLE SHOT EPIDURAL ANESTHESIA KIT

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 Class 2 Recall
SINGLE SHOT EPIDURAL ANESTHESIA KIT
see related information
Date Posted February 17, 2011
Recall Status1 Terminated on September 29, 2012
Recall Number Z-1343-2011
Recall Event ID 57287
Premarket Notification
510(K) Number
K770356 
Product Classification Anesthesia Conduction Kit - Product Code CAZ
Product SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) AK-03000, AM-03000, BH-03000, DH-03000, KC-03000, SA-03001 and SH-03001. Epidural Anesthesia Kit
Code Information AK-03000 Lot Numbers: RF0020735, RF0035260, RF0048279, RF0074386, RF5033131, RF5043814, RF5054886, RF5072941, RF5107406, RF5118270, RF6011018, RF6045801, RF6079491, RF6081233, RF6103625, RF7018712, RF7020460, RF7054076, RF7089370, RF7091000, RF7124568, RF8020964, RF8045881, RF8072854, RF8083651, RF8097339, RF8123912, RF9042571, RF9086457, and RF9125787. AM-3000 Lot Numbers: RF0021939, RF0059446, RF0088369, RF5129734, RF6057409, RF6116605, RF7088733, RF8071779, RF8123969, RF9070874, RF9100154 and RF9114379. BH-03000 Lot Numbers: RF0019618, RF0047612, RF0060793, RF0087742, RF8031875, RF8057376, RF8084126, RF8110915, RF8123973, RF9043981, RF9044684, RF9068606, RF9085979 and RF9100926. DH-03000 Lot Numbers: RF0019622, RF0020877, RF0075585, RF8032658, RF8056830, RF8072009, RF8119791, RF9027240, RF9043983, RF9068609, RF9071992, RF9100168 and RF9112897. KC-03000 Lot Numbers: RF0019721, RF0019727, RF0062036, RF0076951, RF7032320, RF7055209, RF7088801, RF7101703, RF7102262, RF8017549, RF8056557, RF8084129, RF8119798, RF9015804, RF9057951, RF9099001 and RF9126884. SA-03001 Lot Numbers: RF8021034, RF8069022, RF8108468, RF8123597, RF9028904, RF9056328, RF9097652 and RF9101076. SH-03001 Lot Numbers: RF0017728, RF0022606, RF0059476, RF0075693, RF8057235, RF8071390, RF8083724, RF8096352, RF8109029, RF8122700, RF9027311, RF9032220, RF9056916, RF9060668, RF9084115, RF9097727, RF9100901 and RF9114878.
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading, Pennsylvania 19605
For Additional Information Contact Ms. Jody Cadd
610-378-0131 Ext. 3318
Manufacturer Reason
for Recall
Sterility may be compromised.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action 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.
Quantity in Commerce 56,000 units
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CAZ and Original Applicant = ARROW INTL., INC.
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