ClearanceBrief
Recall Z-1571-05 ยท KKX Drape, Surgical, Antimicrobial

North Coast Medi-Tek Inc

Ultrasound probe cover, sterile. Catalog No. 910811.

DateSep 21, 2005 (initiated Jun 7, 2005)
StatusTerminated
ReasonCustomer observed unsealed packages.
Root causeOther
ActionThe recalling firm called their customer and requested the customer to return un-sealed packages.
Quantity30 cases containing 10 units per case.
DistributionThe product was distributed to one consignee: Cone Instruments, 5210 Naiman Parkway, Solon, OH 44139.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K050322MICROTEK EQUIPMENT DRAPES
Microtek Medical, Inc., May 17, 2005