Device, Intravascular Catheter Securement
General Hospital · 21 CFR 880.5210
Recent MDR events
749 adverse event reports on file
- MEDLINEJul 16, 2026MalfunctionCenturion Medical Products, Lp1824619-2026-00019
- STATLOCKJul 10, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04859
- STATLOCKJul 10, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04861
- STATLOCKJul 9, 2026InjuryUnknownMW5190494
- BARD STATLOCKJul 2, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04676
- STATLOCKJun 29, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04548
- STATLOCKJun 23, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04358
- STATLOCKJun 15, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04080
- BARD STATLOCKJun 9, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04006
- STATLOCKMay 18, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-03452
Event type breakdown
Recalls
7 recall events for this product code
- Bard Access Systems Inc.TerminatedMay 19, 2017
StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is
StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
Z-2120-2017 · View FDA record ↗ - Bard Access SystemsTerminatedJan 10, 2017
StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depend
Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
Z-0981-2017 · View FDA record ↗ - Bard Access SystemsTerminatedJan 10, 2017
StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on
Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
Z-0982-2017 · View FDA record ↗ - Bard Access SystemsTerminatedJun 28, 2013
StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible
BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the cathet
Z-1618-2013 · View FDA record ↗ - Merit Medical Systems, IncTerminatedMar 15, 2007
StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain.
Sterility of some units may be compromised due to damaged packaging.
Z-0627-2007 · View FDA record ↗ - Merit Medical Systems, IncTerminatedMar 15, 2007
StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical, Ltd., Great Britain.
Sterility of some units may be compromised due to damaged packaging.
Z-0628-2007 · View FDA record ↗ - Merit Medical Systems, IncTerminatedMar 15, 2007
EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
Sterility of some units may be compromised due to damaged packaging.
Z-0629-2007 · View FDA record ↗
Registered firms
212 firms currently registered for this product code
North American Rescue, Llc.
Greer, SC, US
Weslacova
North Wilkesboro, NC, US
Huizhou Rsp Technology Co.,ltd
Huizhou Guangdong, CN
Shanghai Iso Medical Products Co., Ltd.
SHANGHAI, CN
Henan Maidingkang Medical Technology Co., Ltd.
Changyuan Henan, CN
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Conmed Corporation
WESTBOROUGH, MA, US
Mainline Medical Dental Supply
North York Ontario, CA
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Tidi Products, Llc
NEENAH, WI, US
Martech Medical Products S. De Rl. De Cv.
MEXICALI Baja California, MX
Orta Medical Ltd
TZUR YIGAL Central, IL
O&m Halyard, Inc.
Alpharetta, GA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Steritec Services, Llc
ATHENS, TX, US
Guangdong Tidakang Medical Technology Co., Ltd
ZhongShan City Guangdong, CN
Hubei Junyan Medical Science & Technology Co., Ltd.
Huanggang Hubei, CN
Pharmaplast S.a.e.
ALEXANDRIA Al Iskandariyah, EG
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
Sterigenics U.s., Llc
Haw River, NC, US
Abiomed, Inc.
DANVERS, MA, US
Synergy Health Ede Bv
Venlo Limburg, NL
Interrad Medical Inc
Minneapolis, MN, US
Joykey Industrial (pinghu) Limited
Pinghu City Zhejiang, CN
510(k) clearances
64 clearances for this product code
- Interrad Medical, Inc.Jul 9, 2019
K180994 · SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
- Paraworks Enterprise, Ltd.Jun 3, 1999
K981860 · A P HARNESS
- Byrd Medical Devices, Inc.Oct 11, 1996
K963365 · MULTI-PURPOSE MEDICAL TUBE HOLDER
- Op-Co Medical Products , Ltd.Aug 9, 1995
K941098 · SECURE-SITE
- Venetec, Inc.Sep 29, 1994
K943147 · STATLOCK CV
- Sterile Concepts, Inc.Sep 14, 1994
K943047 · IV START KITS
- Tnt Moborg Intl. , Ltd.Jul 14, 1994
K941940 · IMMOBILE STERILE AND IMMOBILE A/C STERILE
- Tnt Moborg Intl. , Ltd.Jul 14, 1994
K941850 · IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE