ClearanceBrief
Recall Z-2043-2018 ยท FRL Fiber, Medical, Absorbent

Medical Action Industries Inc

Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids. There are no instruction catalogues or manuals included with the product as these

DateDec 11, 2017
StatusTerminated
ReasonProduct sterility potentially compromised.
Root causeProcess control
ActionOn December 11, 2017, the firm sent letters to their consignee informing them to: Immediately examine your inventory and quarantine all product subject to this recall notification. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Replacement product should be available within the next two weeks. Should you have immediate replacement needs in the interim, we do have sufficient inventory of AVI
Quantity31,440 Towels
DistributionUS Distribution to the states of : CO, KS, MN, NY, RI, TX, and WA and Internationally to Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.