Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2043-2018Class II

Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266...

Medical Action Industries, Inc. 306 / initiated 2017-12-11 / Terminated / root cause: manufacturing process

Medical Action Industries Inc began a recall of 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... on . FDA classified it as Class II and gives the reason as "Product sterility potentially compromised". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2043-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medical Action Industries, Inc. 306
Product
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 are intended to be used in accordance with hospital protocol.
Product code
FRL Fiber, Medical, Absorbent
Reason for recall
Product sterility potentially compromised.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
On 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 AVID265, Blue OR Towel Non X-Ray Detectable (4 Towels per Pack), available for immediate distribution. Your assistance is appreciated and necessary to prevent any unintended use of affected product. Please complete and return the enclosed response form as soon as possible. For further questions, please call (828_ 338-7604.
Quantity in commerce
31,440 Towels
Distribution
US Distribution to the states of : CO, KS, MN, NY, RI, TX, and WA and Internationally to Canada
Product codes and lots
Item Code #AVID266, Lot No. 231479, Exp. Date 08/31/2021 and Item Code #AVID266, Lot No. 232564, Exp. Date 11/06/2021.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2043-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2043-2018Class IITerminatedVoluntary: Firm initiated