Spinal Epidural Anesthesia Kit
FDA product code OFT · Class II (moderate risk) · 21 CFR 868.5120 · Anesthesiology
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.
0510(k) clearances
0PMA approvals
40recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3207-2026 | Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925AKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not… | Medline Industries, LP | 07/31/2026Open, Classified |
| Z-3107-2026 Class I | Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF:…Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially… | Medical Action Industries, Inc. 306 | 07/23/2026Open, Classified |
| Z-3067-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-2812-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… | Windstone Medical Packaging, Inc. | 06/17/2026Open, Classified |
| Z-2534-2026 Class II | Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2)…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | Medline Industries, LP | 05/21/2026Open, Classified |
| Z-2442-2026 Class II | Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739BKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, Classified |
| Z-2415-2026 Class II | Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, Classified |
| Z-2232-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | Medline Industries, LP | 04/10/2026Open, Classified |
| Z-2011-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | Medline Industries, LP | 03/19/2026Open, Classified |
| Z-2270-2026 Class II | Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY…B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid… | B Braun Medical Inc | 01/29/2026Open, Classified |
| Z-2267-2026 Class II | Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID…B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid… | B Braun Medical Inc | 01/29/2026Open, Classified |
| Z-2265-2026 Class II | Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH…B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid… | B Braun Medical Inc | 01/29/2026Open, Classified |
| Z-2090-2026 Class II | Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1386-2026 Class II | Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1186-2026 Class II | Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… | Medline Industries, LP | 12/12/2025Open, Classified |
| Z-0511-2026 Class II | MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418MMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | Medline Industries, LP | 09/30/2025Open, Classified |
| Z-1588-2025 Class II | Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | MEDLINE INDUSTRIES, LP - Northfield | 03/03/2025Open, Classified |
| Z-1435-2025 Class II | Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 02/11/2025Open, Classified |
| Z-1021-2025 Class II | Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of…Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the… | B. Braun Medical, Inc. | 12/04/2024Open, Classified |
| Z-0509-2025 Class II | MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF…The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open… | MEDLINE INDUSTRIES, LP - Northfield | 10/16/2024Open, Classified |
| Z-0623-2025 Class II | MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |
| Z-0153-2025 Class II | Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-2741-2024 Class II | Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040HMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2634-2024 Class II | Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2624-2024 Class II | see RES for descriptionMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2442-2024 Class I | Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2156-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | MEDLINE INDUSTRIES, LP - Northfield | 05/18/2023Open, Classified |
| Z-2293-2023 Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | MEDLINE INDUSTRIES, LP - Northfield | 05/15/2023Open, Classified |
| Z-1109-2023 Class II | Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122AThe recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | MEDLINE INDUSTRIES, LP - Northfield | 12/07/2022Open, Classified |
| Z-1063-2023 Class II | Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASICSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-2474-2019 Class II | CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191The filter capacity is not achieved due to damage of the filter membrane. | B. Braun Medical, Inc. | 07/10/2019Terminated |
| Z-2473-2019 Class II | CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189The filter capacity is not achieved due to damage of the filter membrane. | B. Braun Medical, Inc. | 07/10/2019Terminated |
| Z-2472-2019 Class II | CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188The filter capacity is not achieved due to damage of the filter membrane. | B. Braun Medical, Inc. | 07/10/2019Terminated |
| Z-2471-2019 Class II | CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187The filter capacity is not achieved due to damage of the filter membrane. | B. Braun Medical, Inc. | 07/10/2019Terminated |
| Z-2470-2019 Class II | CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186The filter capacity is not achieved due to damage of the filter membrane. | B. Braun Medical, Inc. | 07/10/2019Terminated |
| Z-2469-2019 Class II | CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183The filter capacity is not achieved due to damage of the filter membrane. | B. Braun Medical, Inc. | 07/10/2019Terminated |
| Z-2468-2019 Class II | FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160The filter capacity is not achieved due to damage of the filter membrane. | B. Braun Medical, Inc. | 07/10/2019Terminated |
| Z-2467-2019 Class II | ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115The filter capacity is not achieved due to damage of the filter membrane. | B. Braun Medical, Inc. | 07/10/2019Terminated |
| Z-2466-2019 Class II | ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114The filter capacity is not achieved due to damage of the filter membrane. | B. Braun Medical, Inc. | 07/10/2019Terminated |
| Z-0740-2017 Class II | BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by…BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D… | Becton Dickinson & Company | 11/07/2016Terminated |