Medical Action Industries Inc

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1068-2019Class IILaparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5March 1, 2019
Z-0681-2019Class IILaparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handleNovember 27, 2018
Z-2043-2018Class IIMedical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVDecember 11, 2017
Z-2102-2017Class IIBlue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). April 19, 2017
Z-2101-2017Class IIWhite OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and abApril 19, 2017
Z-1036-2016Class IIPICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action InduFebruary 3, 2016
Z-1952-2014Class IISuture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action IJune 12, 2014
Z-1955-2014Class IISafety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, ArdeJune 12, 2014
Z-1956-2014Class IIMcKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 EacJune 12, 2014
Z-1951-2014Class IILaceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, June 12, 2014
Z-1953-2014Class IIPort-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case,June 12, 2014
Z-1957-2014Class IILaceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, June 12, 2014
Z-1954-2014Class IIMax Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.June 12, 2014
Z-1950-2014Class IILaceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NJune 12, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K042526DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STEApril 25, 2005
K042527SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107November 8, 2004
K022948VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555LNovember 4, 2002
K946019SURGICLA INSTRUMENT KITMarch 20, 1995
K923846BURN DRESSINGSeptember 11, 1992
K884826GAUZE SPONGEDecember 22, 1988
K810685SUTURE REMOVAL KITMarch 26, 1981
K810184LAPAROTOMY SPONGEFebruary 4, 1981