Suture Removal Kit
General, Plastic Surgery · 21 CFR 878.4800
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://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
44 adverse event reports on file
- MCKESSONJul 15, 2026MalfunctionMckesson Medical-surgical Inc.25828486
- MEDLINEJul 7, 2026MalfunctionProductos Medline S.a. De C.v.3004122598-2026-00045
- MEDLINEJul 1, 2026MalfunctionProductos Medline S.a. De C.v.3004122598-2026-00043
- MEDLINEJun 30, 2026MalfunctionProductos Medline S.a. De C.v.3004122598-2026-00040
- MEDLINEJun 19, 2026MalfunctionProductos Medline S.a. De C.v.3004122598-2026-00035
- MEDLINEMay 5, 2026MalfunctionProductos Medline S.a. De C.v.3004122598-2026-00006
- MEDLINEApr 29, 2026MalfunctionProductos Medline S.a. De C.v.3004122598-2026-00004
- MEDLINEApr 22, 2026MalfunctionProductos Medline S.a. De C.v.3004122598-2026-00005
- MCKESSON BRANDSApr 8, 2026InjuryPrimecare Medical (suzhou) Co.,ltd.3015337348-2026-00001
- MEDICAL ACTION INDUSTRIESApr 3, 2026MalfunctionMedical Action Industries Inc.24775687
Event type breakdown
Recalls
16 recall events for this product code
- Medline Industries, LPOpen, ClassifiedFeb 9, 2026
Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Z-1332-2026 · 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-3056-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedMar 29, 2024
Centurion manual surgical kits labeled as:
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Z-1445-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedFeb 25, 2024
Medline Kits, trays, and packs labeled as follows:
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Z-1114-2024 · View FDA record ↗ - Customed, IncTerminatedApr 14, 2016
Catalog Number: 900010 SUTURE REMOVAL KIT
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1398-2016 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
SUTURE REMOVAL KIT CUSTOMED 100/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2549-2015 · View FDA record ↗ - Customed, IncTerminatedDec 16, 2014
Surgical packs (includes trays, bags and kits)
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes (QSR) and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Z-0237-2015 · View FDA record ↗ - Medical Action Industries IncTerminatedJul 1, 2014
Laceration/Suture Removal, 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-1951-2014 · View FDA record ↗ - Customed, IncTerminatedMar 21, 2012
Suture removal kit, catalog# 900-010
The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-1251-2012 · View FDA record ↗ - Customed, IncTerminatedMar 21, 2012
Skin Stapler Removal Kit , catalog# 900-782
The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-1259-2012 · View FDA record ↗
Registered firms
58 firms currently registered for this product code
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Lsl Healthcare
Niles, IL, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Sterigenics U.s., Llc
Charlotte, NC, US
Nuevo Laredo Directo Al Cliente
Nuevo Laredo Tamaulipas, MX
Busse Hospital Disposables
HAUPPAUGE, NY, US
Ssc- Surgical Specialties Corporation
Chula Vista, CA, US
Medline Soluciones Medicas
Nuevo Laredo Tamaulipas, MX
Allmed Industrial Limited
Shenzhen City Guangdong, CN
Vygon Mfg
DOVER, NH, US
Sterigenics Us Llc
Grand Prairie, TX, US
Biotronix Healthcare Industries Inc.
Orlando, FL, US
Jiangsu Classic New-type Medical Products Co., Ltd
Yancheng Jiangsu, CN
Dukal Llc
Ronkonkoma, NY, US
Deroyal Intercontinental, S.r.l.
SANTIAGO, DO
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Primecare Medical (suzhou) Co.,ltd.
Changshu Jiangsu, CN
Conod Medical Co.,limited
Changshu Jiangsu, CN
Honduras Kitting, S.a.
Villanueva Cortes, HN
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Trinity Sterile, Inc.
SALISBURY, MD, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Medline Industries, Lp - Laredo
LAREDO, TX, US
Allmed Medical Products Co., Ltd.
Zhijiang City Hubei, CN
Resource Optimization & Innovation, Llc
Nashville, TN, US
510(k) clearances
15 clearances for this product code
- Amsino International, Inc.May 2, 2005
K050656 · AMSINO SUTURE REMOVAL KIT
- Continental Medical Laboratories, Inc.Feb 14, 1997
K964827 · PROD. NO. 01-132 - SUTURE REMOVAL KIT
- Grand Medical ProductsNov 27, 1996
K963714 · GRAND MEDICAL SUTURE REMOVAL KIT
- Sterile Concepts, Inc.Jul 29, 1994
K943046 · SKIN STAPLE REMOVAL TRAYS
- Clinical Resources, Inc.Apr 22, 1994
K941465 · SUTURE REMOVAL KIT
- Carapace, Inc.Nov 5, 1993
K931597 · CARAPACE INCISION AND DRAINAGE TRAYS
- Customed, Inc.Jun 7, 1993
K925015 · STERILE SUTURE REMOVAL KIT
- American Healthcare Supply Co., Inc.Mar 23, 1993
K924834 · PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957)