FDA Enforcement
Class II
Terminated
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.
Recall: Z-2043-2018
·
Reported June 6, 2018
Enforcement
- Recall Number
- Z-2043-2018
- Event ID
- 80147
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medical Action Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 6, 2018
- Initiation Date
- December 11, 2017
- Classification Date
- May 31, 2018
- Termination Date
- September 22, 2020
- Address
- 25 Heywood Rd, N/A, Arden, NC, 28704-9302, United States
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.
Reason
Product sterility potentially compromised.
Code Info
Item Code #AVID266, Lot No. 231479, Exp. Date 08/31/2021 and Item Code #AVID266, Lot No. 232564, Exp. Date 11/06/2021.
Distribution
US Distribution to the states of : CO, KS, MN, NY, RI, TX, and WA and Internationally to Canada
Quantity
31,440 Towels