Spinal Epidural Anesthesia Kit
Anesthesiology · 21 CFR 868.5120
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. 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
286 adverse event reports on file
- MEDLINEJul 22, 2026MalfunctionProductos Medline S.a. De C.v.3004122598-2026-00052
- MEDLINEJul 17, 2026MalfunctionMedline Industries, Lp1417592-2026-06114
- MEDLINEJul 15, 2026MalfunctionMedline Industries, Lp1417592-2026-05887
- MEDLINEJul 14, 2026MalfunctionProductos Medline S.a. De C.v.1417592-2026-05572
- MEDLINEJul 14, 2026MalfunctionProductos Medline S.a. De C.v.1417592-2026-05573
- MEDLINEJul 7, 2026MalfunctionMedline Industries, Lp1417592-2026-04624
- ESPOCAN®Jul 6, 2026MalfunctionB. Braun Medical Inc.2521402-2026-00680
- MEDLINEJul 6, 2026MalfunctionMedline Industries, Lp1417592-2026-04477
- MEDLINEJun 25, 2026MalfunctionMedline - Mexicali1417592-2026-03233
- CSE TRAY MEDLINEJun 16, 2026MalfunctionMedline Industries Inc25518012
Event type breakdown
Recalls
37 recall events for this product code
- Windstone Medical Packaging, Inc.Open, ClassifiedJul 27, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Z-2812-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJun 29, 2026
Medline Convenience Kits:
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Z-2534-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJun 12, 2026
Medline CCI Nerve Block Tray
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Z-2415-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJun 12, 2026
Medline convenience kits:
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Z-2442-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedMay 29, 2026
Brand Name: B. BRAUN MEDICAL INC.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2265-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedMay 29, 2026
Brand Name: B. BRAUN MEDICAL INC.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2267-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedMay 29, 2026
Brand Name: B. BRAUN MEDICAL INC.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2270-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedMay 28, 2026
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as:
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Z-2232-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedMay 7, 2026
Medline Convenience Kits:
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2090-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedApr 30, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Z-2011-2026 · View FDA record ↗
Registered firms
24 firms currently registered for this product code
B. Braun Medical Inc.
BETHLEHEM, PA, US
Honduras Kitting, S.a.
Villanueva Cortes, HN
Midwest Sterilization Corp.
JACKSON, MO, US
Cardinal Health 200, Llc
El Paso, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Sterigenics U.s., Llc
Atlanta, GA, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Cardinal Health 200, Llc
Waukegan, IL, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Isomedix Operations Inc
EL PASO, TX, US
Medline Industries, Lp - Spt
Waukegan, IL, US
Midwest Sterilization Corp.
LAREDO, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
B. Braun Medical Inc.
Allentown, PA, US
Vygon Mfg
DOVER, NH, US
B. Braun Us Device Manufacturing Llc
ALLENTOWN, PA, US
Medline Soluciones Medicas
Nuevo Laredo Tamaulipas, MX
Isomedix Operations Inc
El Paso, TX, US
Medline Industries, Lp - Laredo
LAREDO, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Nuevo Laredo Directo Al Cliente
Nuevo Laredo Tamaulipas, MX
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Chs Usa Incorporated
PEACHTREE CITY, GA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.