ClearanceBrief
Recall Z-0281-04 ยท GAA Needle, Aspiration And Injection, Disposable

Novosci Corp

Pediatric Air Aspirator Needle manufactured by Novosci Corp., The Woodlands, TX

DateJul 20, 2004 (initiated Nov 24, 2003)
StatusTerminated
ReasonThe firm packaged Modified Air Aspirator Needles into Pediatric Air Aspirator Needle boxes.
Root causeOther
ActionThe firm has contacted the 3 consignees by either phone or email and sent a formal letter to the consignees via FED-EX on 11/24/2003
Quantity200 Units
DistributionTX, IL and Germany
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K801393AIR ASPIRATOR NEEDLE
Texas Medical Products, Inc., Jun 30, 1980