ClearanceBrief
Recall Z-1409-04 ยท GBW Catheter, Peritoneal

Arrow International Inc

Peritoneal Lavage Kits, Model number AK-09001

DateAug 25, 2004 (initiated Aug 2, 2004)
StatusTerminated
Reasonwrong introducer needle in some kits
Root causeOther
ActionThe recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product.
Quantity9100 units
DistributionThe product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.