Aspen Surgical Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
23
510(k) Clearances
2
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2388-2021Class IIJessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit SJuly 23, 2021
Z-2389-2021Class IIMarco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S7July 23, 2021
Z-2390-2021Class IINorton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400July 23, 2021
Z-1432-2014Class II15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) March 20, 2014
Z-1424-2014Class II10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closeMarch 20, 2014
Z-1423-2014Class II7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed woundMarch 20, 2014
Z-1422-2014Class IISaber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suMarch 20, 2014
Z-1429-2014Class II10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended foMarch 20, 2014
Z-1421-2014Class IISaber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to providMarch 20, 2014
Z-1425-2014Class II15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closeMarch 20, 2014
Z-1418-2014Class II10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended fMarch 20, 2014
Z-1427-2014Class II10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) March 20, 2014
Z-1431-2014Class II10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended fMarch 20, 2014
Z-1426-2014Class II19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closeMarch 20, 2014
Z-1435-2014Class II7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain March 20, 2014
Z-1420-2014Class II15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) March 20, 2014
Z-1430-2014Class II7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended foMarch 20, 2014
Z-1428-2014Class II10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) March 20, 2014
Z-1433-2014Class II19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) March 20, 2014
Z-1419-2014Class II10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) March 20, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K030339CAUTERY TIP CLEANER, MODEL-TC-100March 7, 2003
K020304DISPOSABLE LIGHT HANDLE AND ADAPTORFebruary 14, 2002