Suture Kit
General, Plastic Surgery · 21 CFR 878.4830
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
40 adverse event reports on file
- MEDICAL ACTION INDUSTRIES INC LACERATION KITJul 20, 2026MalfunctionMedical Action Industries Inc 306MW5190873
- KIT: LACERATION 20/CSJun 29, 2026InjuryMedical Action Industries1030451-2026-00028
- WOUND KITMar 17, 2026MalfunctionMedical Action Industries1030451-2026-00003
- LACERATION KITMar 17, 2026MalfunctionMedical Action Industries1030451-2026-00004
- LACERATION KITMar 17, 2026MalfunctionMedical Action Industries1030451-2026-00005
- LACERATION KITMar 17, 2026MalfunctionMedical Action Industries1030451-2026-00006
- CARDINAL HEALTHJun 17, 2025MalfunctionCardinal Health 200, Llc22231208
- CARDINAL HEALTHApr 18, 2025MalfunctionCardinal Health 200, Llc21864601
- CARDINAL HEALTHApr 18, 2025MalfunctionCardinal Health 200, Llc21864627
- CARDINAL HEALTHApr 18, 2025MalfunctionCardinal Health 200, Llc21864663
Event type breakdown
Recalls
10 recall events for this product code
- LSL Healthcare Inc.Open, ClassifiedApr 22, 2026
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Z-1933-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJan 28, 2026
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Z-1194-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-3026-2024 · View FDA record ↗ - Medical Action Industries IncTerminatedJul 1, 2014
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Z-1950-2014 · View FDA record ↗ - Medical Action Industries IncTerminatedJul 1, 2014
Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Z-1952-2014 · View FDA record ↗ - Medical Action Industries IncTerminatedJul 1, 2014
Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Z-1953-2014 · View FDA record ↗ - Medical Action Industries IncTerminatedJul 1, 2014
Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Z-1954-2014 · View FDA record ↗ - Medical Action Industries IncTerminatedJul 1, 2014
Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Z-1955-2014 · View FDA record ↗ - Medical Action Industries IncTerminatedJul 1, 2014
McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgic
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Z-1956-2014 · View FDA record ↗ - Medical Action Industries IncTerminatedJul 1, 2014
Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Z-1957-2014 · View FDA record ↗
Registered firms
38 firms currently registered for this product code
Avid Medical, Inc. A Medical Action Ind. Company 305
TOANO, VA, US
Sterigenics U.s., Llc
Charlotte, NC, US
Systagenix Wound Management Manufacturing Limited
North Yorkshire, GB
Sterigenics U.s., Llc
Atlanta, GA, US
Bailey Instruments Ltd
Manchester, GB
Sterigenics U.s., Llc
Ontario, CA, US
Sterigenics Us Llc
Grand Prairie, TX, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Riverpoint Medical Llc
Portland, OR, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Hubei Lanbin Medical Group Co., Ltd.
Xiaogan City Hubei, CN
Covidien
North Haven, CT, US
Teleflex Medical Llc
MANSFIELD, MA, US
Isomedix Operations Inc
EL PASO, TX, US
Isomedix Operations Inc
El Paso, TX, US
Resource Optimization & Innovation, Llc
Nashville, TN, US
Cardinal Health 200, Llc
Waukegan, IL, US
Ningbo Greatcare Medical Instruments Co., Ltd.
NINGBO Zhejiang, CN
Cayenne Medical, Inc.
SCOTTSDALE, AZ, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Deroyal Industries, Inc.
POWELL, TN, US
Lsl Healthcare
Niles, IL, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Vygon Usa
Lansdale, PA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.