Nerve Block Tray
FDA product code OGJ · Class II (moderate risk) · 21 CFR 868.5140 · 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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
0510(k) clearances
0PMA approvals
46recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3106-2026 Class I | Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP…Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially… | Medical Action Industries, Inc. 306 | 07/23/2026Open, Classified |
| Z-2814-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray -…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-2535-2026 Class II | Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | Medline Industries, LP | 05/21/2026Open, Classified |
| Z-2234-2026 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-2013-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | Medline Industries, LP | 03/19/2026Open, Classified |
| Z-1714-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1832-2026 Class II | Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517DThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-2116-2026 Class II | Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150CMedline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1387-2026 Class II | Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150CMedline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1589-2025 Class II | Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF…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-0511-2025 Class II | MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2)…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-2635-2024 Class II | Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 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-2626-2024 Class II | See RES 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-2443-2024 Class I | Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE…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-2158-2023 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-2295-2023 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-0326-2023 Class II | Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is… | Busse Hospital Disposables, Inc. | 10/21/2022Open, Classified |
| Z-0325-2023 Class II | Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is… | Busse Hospital Disposables, Inc. | 10/21/2022Open, Classified |
| Z-1178-2022 Class II | Procedural Accessory Kit Catalog Number: 9665R2Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1175-2022 Class II | Joint Injection Tray Catalog Number: 8561R1Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1174-2022 Class II | Single Shot Epidural Tray - 18G Catalog Number: 8139R2Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1173-2022 Class II | Pump Refill Kit Catalog Number: 7347R1Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1172-2022 Class II | Single Shot Epidural Tray Catalog Number: 6797R2Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1171-2022 Class II | Nerve Block Tray Catalog Number: 6796R3Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1170-2022 Class II | Sterile Epidural Tray Catalog Number: 6259R2Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1169-2022 Class II | Single Shot Epidural Tray Catalog Number: 6183R1Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1168-2022 Class II | Cervical Tray Catalog Number: 3765R2Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1167-2022 Class II | Nerve Block Tray Catalog Number: 3764R2Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1164-2022 Class II | Pain Tray Catalog Number: 9883Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1163-2022 Class II | MBB Tray Catalog Number: 9882Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1162-2022 Class II | Universal Nerve Block Tray Catalog Number: 9818Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1161-2022 Class II | Universal Nerve Block Tray Catalog Number: 9779Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1160-2022 Class II | Nerve Block Tray Catalog Number: 9342Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1159-2022 Class II | Single Shot Epidural Tray Catalog Number: 8417Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1158-2022 Class II | Nerve Block Tray Catalog Number: 8415Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1156-2022 Class II | Port Tray Catalog 7607Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1155-2022 Class II | Epidural Tray Catalog 1577Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1154-2022 Class II | Universal Tray Catalog 1567Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1153-2022 Class II | Epidural Tray Catalog 1307Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1152-2022 Class II | Single Shot Epidural Tray Catalog 1292Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1151-2022 Class II | Single Shot Epidural Tray Catalog 1165Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1149-2022 Class II | Cervical Tray Catalog 1089Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1148-2022 Class II | Procedure Tray Catalog 1065Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional… | Busse Hospital Disposables, Inc. | 02/22/2022Terminated |
| Z-1555-2021 Class I | Kit: Injection REVIEW MAI Kit Part Number: 74736Medical convenience kits are being recalled due to a potential breach in the package integrity of a… | Medical Action Industries, Inc. 306 | 04/09/2021Terminated |
| Z-1519-2020 Class II | Custom procedure trays containing medical components needed to facilitate patient…The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at… | Avid Medical, Inc. | 02/18/2020Terminated |
| Z-0943-2015 Class II | Nerve Block Tray (Nerve Block convenience kit)According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer… | Centurion Medical Products Corporation | 10/23/2014Terminated |