Ring, Laparotomy
Gastroenterology, Urology · 21 CFR 876.4730
Recent MDR events
4 adverse event reports on file
- CADD CASSETTE RESERVOIRS - FLOW STOP NRFIDec 31, 2025MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v.3012307300-2025-13980
- DISPOSABLE LAPDec 31, 2004MalfunctionUnk566176
- WOLF-YOON FALLOPIAN RING APPLICATORJul 22, 1994MalfunctionRichard Wolf, Gmbh1418479-1994-09056
- LIGACLIP ERCAFeb 4, 1994InjuryEthicon Endo Surgery7789
Event type breakdown
Most-reported manufacturers
Recalls
10 recall events for this product code
- Customed, IncTerminatedAug 29, 2014
Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, g
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2305-2014 · View FDA record ↗ - Customed, IncTerminatedAug 29, 2014
Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes, table cover, drape
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2307-2014 · View FDA record ↗ - Customed, IncTerminatedAug 29, 2014
LAPAROTOMY PACK - CUSTOMED-
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2312-2014 · View FDA record ↗ - Customed, IncTerminatedAug 29, 2014
LAPAROTOMY PACK -
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2315-2014 · View FDA record ↗ - Customed, IncTerminatedAug 29, 2014
LAPAROTOMY PACK - (I) UTILITY BOWL 16oz
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2316-2014 · View FDA record ↗ - Customed, IncTerminatedAug 29, 2014
MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2326-2014 · View FDA record ↗ - Customed, IncTerminatedAug 29, 2014
LAPAROTOMY BASIC PACK- CUSTOMED-
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2330-2014 · View FDA record ↗ - Customed, IncTerminatedAug 29, 2014
LAPAROTOMY PACK -
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2353-2014 · View FDA record ↗ - Customed, IncTerminatedAug 29, 2014
LAPAROTOMY PACK-
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2364-2014 · View FDA record ↗ - Customed, IncTerminatedAug 29, 2014
PREMIUM LAPAROTOMY PACK - CUSTOMED-
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2384-2014 · View FDA record ↗
Registered firms
20 firms currently registered for this product code
Aesculap, Inc.
CENTER VALLEY, PA, US
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Hangzhou Endo Medical Instrument Co.,ltd
hangzhou Zhejiang, CN
Integra Lifesciences Corporation
Princeton, NJ, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Melpex Beauty Instruments
Sialkot Punjab, PK
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Teleflex Medical Llc
Morrisville, NC, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Precision Medical Manufacturing Llc
Wheeling, IL, US
Hebumedical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Xinhua Surgical Instrument Co. Ltd.
ZIBO Shandong, CN
Millennium Surgical Corp
Schaumburg, IL, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Greens Surgicals Private Limited
Vadodara Gujarat, IN
Wexler Surgical, Inc.
HOUSTON, TX, US
Symmetry Surgical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.