Arden, NC, United States
Medical Action Industries Inc recalls
3 recalls recorded since 2018, most recently on 1 March 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 March 2019
- Terminated
- 6 April 2021
- Reason
- Potential lack of sterility assurance
- Distribution
- Distributed nationwide to AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WY. Also distributed to Canada and Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1068-2019
- Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Mod
Terminated Class II Medical devices
- Recall started
- 27 November 2018
- Terminated
- 8 February 2019
- Reason
- Potential compromise of product sterility due to breach of sterile barrier.
- Distribution
- Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0681-2019
- Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are
Terminated Class II Medical devices
- Recall started
- 11 December 2017
- Terminated
- 22 September 2020
- Reason
- Product sterility potentially compromised.
- Distribution
- US Distribution to the states of : CO, KS, MN, NY, RI, TX, and WA and Internationally to Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2043-2018
- 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 absorb
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.