510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1671-2009

12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E...

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2009-05-08 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Arrow International Inc began a recall of 12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. The large-bore multiple-lumen... on . The reason FDA records is "Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1671-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arrow International LLC (subsidiary of Teleflex Incorporated)
Product
12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall
Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
The recalling firm issued an Urgent Medical Device Recall letter dated 5/11/09 to their customers informing them of the problem and the potential consequences. The letter asked customers to check their stock, cease use and distribution, and quarantine the affected products. They are to contact Arrow's Customer Service Department at 1-800-523-8446 for a Return Authorization Number; complete the Recall Acknowledgement & Stock Status Form and fax to 1-800-343-2935; and return any affected product. The letter states that Arrow can provide either replacement with a similar product at no charge or credit customers' accounts. Additional information or clarification can be obtained by calling Customer Service at 1-800-523-8446.
Quantity in commerce
46,610 total
Distribution
Worldwide Distribution -- USA, Belgium, Canada, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Lithuania, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, and United Kingdom.
Product codes and lots
Product number AK-12123-H - Lot numbers: RF8045004, RF8072289, RF8084254, RF8107640, RF8108841, RF8110482, RF8122717, RF9027113, RF9030981; Product number CS-12123-E - Lot numbers: RF8032041, RF8043417, RF8058142, RF8060023, RF8072220, RF8084333, RF8097145, RF8109080, RF8110116, RF9015982, ZF7126427, ZF8027168, ZF8027448, ZF8037862, ZF8048194, ZF8048672, ZF8059197, ZF8069577, ZF8090983, ZF8091196, ZF8101854, ZF8102010, ZF8112852, ZF8124161, ZF9014366, ZF9025408, ZF9035840, ZF9046856; Product number MA-12123 - Lot numbers: ZF8027407, ZF8059146, ZF8090984, ZF9014354, ZF9046854; and  Product number MC-12123 - Lot numbers: RF8057141 and RF8083743.