Z-1343-2011

SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) AK-03000, AM-03000, BH-03000, DH-03000, KC-03000...

Name: Z-1343-2011 SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) AK-03000, AM-03000, BH-03000, DH-03000, KC-03000...
Creator: Arrow International Inc
Published: 2010-10-29
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2010-10-29 / Terminated / root cause: sterility

FDA source

Arrow International Inc began a recall of 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 on 2010-10-29. The reason FDA records is "Sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1343-2011
Status: Terminated
Initiated: 2010-10-29
Posted: 2011-02-17
Terminated: 2012-09-29
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Sterility may be compromised.
Root cause tag: sterility
FDA root cause: Other
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.
Product codes and lots: 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.

Product code CAZ

K770356Class IIAnesthesia Kit, Epidural, Single ShotArrow Intl., Inc. / cleared 1977-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)