ClearanceBrief
Recall Z-0710-2007 ยท KMF Bandage, Liquid

Coloplast Corp Skin Care Div

Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA, #11701-159-36, #1063.

DateApr 4, 2007 (initiated Feb 14, 2007)
StatusTerminated
ReasonColoplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).
Root causeOther
ActionThe initial consignees of the product were contacted and notified of the recall February 14, 2007. The consignees were asked to contact their customers immediately and return all product to the manufacturer.
Quantity654 boxes, 12 bottles per box for a total of 7,848 bottles
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K983519COMFEEL SEASORB DRESSING
Coloplast Corp., Dec 30, 1998