ClearanceBrief
Recall Z-0382-04 ยท NAD Dressing, Wound, Occlusive

Kendall Healthcare Products Co

Kendall Curity Disposable Laparotomy Sponges, 12 in x 12 in, Sterile Product Number: 6034

DateJul 20, 2004 (initiated Jan 8, 2004)
StatusTerminated
ReasonSterility compromised due to lack of package seal integrity
Root causeOther
ActionKendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified.
Quantity188 cases
DistributionAL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO,NC NE, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.