Carrier, Ligature
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
9 adverse event reports on file
- VASOVIEW HEMOPROApr 25, 2024MalfunctionMaquet Cardiovascular Llc2242352-2024-00422
- NOVAPASS REVERDIN SUTURE PASSERMay 15, 2018InjuryCook Inc1820334-2018-01464
- NOVAPASS REVERDIN SUTURE PASSERMay 15, 2018InjuryCook Inc1820334-2018-01469
- PEREYRA RAZ LIGATURE CARRIERSep 25, 2017Cook Inc.MW5072428
- NOVAPASS STRAIGHT SUTURE PASSERJan 23, 2017InjuryCook Inc1820334-2017-00085
- NOVAPASS REVERDIN SUTURE PASSERSep 13, 2016InjuryCook Inc1820334-2016-00943
- SMITH & NEWMANApr 23, 2002Malfunction*MW1024883
- SOMNUSFeb 19, 2002OtherGyrus Ent Llc1037007-2002-00001
- LAPAROSCOPIC TROCARJan 17, 1995InjuryAutosuture Co.20005
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Conmed CorporationTerminatedOct 27, 2006
ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431. --- The product is distributed sterile in heat-seal
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
Z-0096-2007 · View FDA record ↗ - Cook Inc.TerminatedUnknown
Pereyra-Raz Ligature Carrier
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Z-2534-2017 · View FDA record ↗ - Cook Inc.TerminatedUnknown
Pereyra Ligature Carrier 75
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Z-2535-2017 · View FDA record ↗ - Cook Inc.TerminatedUnknown
Stamey Needle
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Z-2536-2017 · View FDA record ↗
Registered firms
76 firms currently registered for this product code
Cook Incorporated
Bloomington, IN, US
Cypris Medical, Inc.
Evanston, IL, US
Cygnus Medical Llc
Branford, CT, US
Qsa Surgical (pvt) Ltd.
SIALKOT Punjab, PK
Ambler Surgical, Llc
EXTON, PA, US
Max Hauser Suddeutsche Chirurgiemechanik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
A.handte Medizintechnik Gmbh & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Surgix Medical Llc
Spring, TX, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Hive International Pvt Ltd.
Sialkot Punjab, PK
Steris Corporation
Saint Louis, MO, US
Steri-tek, Llc
Lewisville, TX, US
Zain's Medical Image
SIALKOT Punjab, PK
4 Med Ltd.
Nahal-Oz Southern, IL
Trident Manufacturing, Inc.
Pingree Grove, IL, US
Isomedix Operations, Inc.
Libertyville, IL, US
Lynx Medical Nj
Franklin, NJ, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Teleflex Medical Llc
Morrisville, NC, US
Marina Medical Instruments, Inc.
Davie, FL, US
Surgicrafts
Sialkot Punjab, PK
International Manufacturing Solutions Operaciones
Cd. Juarez Chihuahua, MX
Dufner Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Medicon, E.g.
TUTTLINGEN Baden-Wurttemberg, DE
510(k) clearances
5 clearances for this product code
- Cypris MedicalMay 3, 2024
K240185 · Cypris eXact Suture Placement Device
- Solos Endoscopy, Inc.Apr 18, 1990
K900958 · GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM
- Solos Endoscopy, Inc.Apr 18, 1990
K900959 · GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED
- Cook Ob/GynNov 14, 1988
K884553 · STAMEY NEEDLE
- Cox-Uphuff Intl.Nov 13, 1987
K874342 · LIGATURE CARRIER/PACKER, HYDROXYLAPATITE