FDA recall record

Medical Action Industries Inc recall — FDA Z-2043-2018

Product sterility potentially compromised.

Class IIclassification
Z-2043-2018official record ID
Jun 6, 2018report date

Recall record at a glance

Official recordZ-2043-2018
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmMedical Action Industries Inc.
Report dateJun 6, 2018
Recall initiation dateDec 11, 2017
Quantity31,440 Towels
LocationArden, NC, United States

Official product description

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.

Why the product was recalled

Product sterility potentially compromised.

Distribution information

US Distribution to the states of : CO, KS, MN, NY, RI, TX, and WA and Internationally to Canada

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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