FDA Device

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

Hazard

Sterility may be compromised.

What You Should Do

Remedy

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.

Products

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
Brand
Arrow International Inc
UPC
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.

Units Affected

56,000 units