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Manufacturers
Aspen Surgical Products, Inc.
Manufacturer Address
Aspen Surgical Products, Inc., 6945 Southbelt Dr Se, Caledonia MI 49316-7664
Manufacturer Parent Company (2017)
Hill-Rom Holdings, Inc
Source
USFDA
28 Events
Recall of Device Recall Walcott RX Products Corneal Marking Pad Sterile
Recall of Device Recall Viscot Corneal Marking Pad, Sterile
Recall of Device Recall OcuSoft Corneal Marking Oad, Sterile
Recall of Device Recall Eagle Labs Corneal Marking Pad, Sterile
Recall of Device Recall Aspen Corneal Marking Pad Sterile
Recall of Device Recall Oasis Corneal Ink Stamp Sterile
Recall of Device Recall 7mm Drain Kit Flat 3/4 Perforated with 100ml SVac Bulb Evacuator, Sterile (10/case)
Recall of Device Recall 7mm Drain Kit Flat Full Perforated with Trocar and 100ml SVac Bulb Evacuator, Sterile (10/case)
Recall of Device Recall 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case)
Recall of Device Recall 15FR Drain Kit Round End Perforated with Trocar and 100ml SVac Bulb Evacuator, Sterile (10/case)
Recall of Device Recall 10mm Drain Kit Flat Full Perforated with 100ml SVac Bulb Evacuator, Sterile (10/case)
Recall of Device Recall 7mm Drain Kit Flat Full Perforated with 100ml SVac Bulb Evacuator, Sterile (10/case)
Recall of Device Recall 10mm Drain Kit Flat 3/4 Perforated with 100ml SVac Bulb Evacuator, Sterile (10/case)
Recall of Device Recall 10mm Drain Kit Flat Full Perforated with Trocar and 100ml SVac Bulb Evacuator, Sterile (10/case)
Recall of Device Recall 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml SVac Bulb Evacuator, Sterile (10/case)
Recall of Device Recall 19FR Drain Kit Full Fluted with Trocar and 100ml SVac Bulb, Sterile (10/case)
Recall of Device Recall 15FR Drain Kit Full Fluted with Trocar and 100ml SVac Bulb, Sterile (10/case)
Recall of Device Recall 10FR Drain Kit Full Fluted with Trocar and 100ml SVac Bulb, Sterile (10/case)
Recall of Device Recall 7mm Drain Kit Fluted 4 Channel with 100ml SVac Bulb, Sterile (10/case)
Recall of Device Recall Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case)
Recall of Device Recall Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case)
Recall of Device Recall 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case)
Recall of Device Recall 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case)
Recall of Device Recall 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case)
Recall of Device Recall 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case)
Recall of Device Recall Wound Closure Strips
Recall of Surgidyne SVac round fluted channel silicone drain kit
Recall of Surgidyne SVac round fluted channel silicone drain
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28 devices in the database
Device Recall Walcott RX Products Corneal Marking Pad Sterile
Model / Serial
2013-01-12, 2013-09-13.
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
Product Description
Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery.
Device Recall Viscot Corneal Marking Pad, Sterile
Model / Serial
2010-10-14, 2010-12-02, 2012-02-03, 2012-03-17, 2012-04-14, 2012-06-23, 2012-07-20, 2012-10-12, 2012-11-30, 2013-03-12, 2013-04-08, 2013-04-22, 2013-07-28, 2013-09-01.
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
Product Description
Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery.
Device Recall OcuSoft Corneal Marking Oad, Sterile
Model / Serial
2012-08-24, 2012-10-12, 2012-11-17, 2012-12-15.
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
Product Description
CYNACON OcuSOFT LASIK Marker Pads, REF 750-093, Rx Only, Sterile. For use in ophthalmic surgery.
Device Recall Eagle Labs Corneal Marking Pad, Sterile
Model / Serial
2010-12-09, 2013-02-23, 2013-08-12, 2013-09-24.
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
Product Description
Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery.
Device Recall Aspen Corneal Marking Pad Sterile
Model / Serial
2010-10-07, 2012-10-12, 2012-11-30, 2012-12-15, 2013-04-09, 2013-04-23, 2013-05-21, 2013-09-01, 2013-10-01.
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
Product Description
Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery.
23 more
3 manufacturers with a similar name
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Aspen Surgical Products, Inc.
Manufacturer Address
Aspen Surgical Products, Inc., 7425 Clyde Park Ave Sw Ste G, Byron Center MI 49315-8373
Source
USFDA
Aspen Surgical Products, Inc..
Manufacturer Parent Company (2017)
Hill-Rom Holdings, Inc
Manufacturers representative
Sehat Al-Jazeera EST.
Source
SFDA
Aspen Surgical Products, Inc.
Manufacturer Address
Aspen Surgical Products, Inc., 7425 Clyde Park SW, Ste. G, Byron Center MI 49315
Source
USFDA
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