Labor And Delivery Kit
FDA product code MLS · Class II (moderate risk) · 21 CFR 884.4530 · Obstetrics/Gynecology
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
6510(k) clearances
0PMA approvals
46recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961993 | Birthday Kit (Obstetrical Delivery Kit)MLS · Traditional | Devon Industries, Inc. | 07/03/1996SE |
| K960243 | CPR C-Section Delivery PackMLS · Traditional | Custom Pack Reliability | 05/23/1996SE |
| K940518 | C-Section TrayMLS · Traditional | Cush Medical Products | 08/18/1994SEKD |
| K932216 | C-Section, Labor & Delivery Trays (Packs)MLS · Traditional | Associated Medical Products Co. | 04/19/1994SESK |
| K936120 | Labor and Delivery TrayMLS · Traditional | Cush Medical Products | 03/30/1994SEKD |
| K931722 | Carapace Labor and Delivery SetsMLS · Traditional | Carapace, Inc. | 03/23/1994SEKD |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3076-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3059-2026 Class II | Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-2545-2026 Class II | Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699AThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | Medline Industries, LP | 05/21/2026Open, Classified |
| Z-2501-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | Medline Industries, LP | 05/04/2026Open, Classified |
| Z-2429-2026 Class II | Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895FKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, Classified |
| Z-1727-2026 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-1845-2026 Class II | Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813DThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-2108-2026 Class II | Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1414-2026 Class II | Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-0523-2026 Class II | MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G…Medline 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-0173-2026 Class II | Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK -…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | American Contract Systems Inc. | 09/04/2025Open, Classified |
| Z-2469-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | American Contract Systems Inc | 07/14/2025Open, Classified |
| Z-1611-2025 Class II | Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY 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-1446-2025 Class II | Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 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-1348-2025 Class II | DELIVERY PACK , Model No SGDV22D-01 SGDV22EACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | American Contract Systems Inc | 02/06/2025Open, Classified |
| Z-1344-2025 Class II | LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | American Contract Systems Inc | 02/06/2025Open, Classified |
| Z-1341-2025 Class II | BORN ON ARRIVAL KIT , Model No LLBN11BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | American Contract Systems Inc | 02/06/2025Open, Classified |
| Z-1338-2025 Class II | LABOR & DELIVERY PACK, Model Nos LLLD19HACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | American Contract Systems Inc | 02/06/2025Open, Classified |
| Z-1047-2025 Class I | regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee…There is a potential for the Inline Controller to be using the spring out of specification causing a loss of… | ROi CPS LLC | 12/26/2024Open, Classified |
| Z-0791-2025 Class II | Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LFCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | MEDLINE INDUSTRIES, LP - Northfield | 11/21/2024Open, Classified |
| Z-0515-2025 Class II | MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, 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-0641-2025 Class II | MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |
| Z-0174-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, 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-3238-2024 Class II | Vaginal Delivery, ASDV25B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | American Contract Systems, Inc. | 08/07/2024Open, Classified |
| Z-3228-2024 Class II | Endovascular AAA Pack, ESED52B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | American Contract Systems, Inc. | 08/07/2024Open, Classified |
| Z-3044-2024 Class II | Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 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-2779-2024 Class II | Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY…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-2772-2024 Class II | Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 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-2760-2024 Class II | Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR…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-2229-2024 Class II | Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure…Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach… | MEDLINE INDUSTRIES, LP - Northfield | 03/14/2024Open, Classified |
| Z-2227-2024 Class II | Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure…Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach… | MEDLINE INDUSTRIES, LP - Northfield | 03/14/2024Open, Classified |
| Z-0829-2024 Class II | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | American Contract Systems, Inc. | 11/29/2023Open, Classified |
| Z-1122-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-2187-2023 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-2332-2023 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-1433-2023 Class II | Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major…The recalling firm was notified by their supplier that the light handle covers may separate from the light… | ROi CPS LLC | 03/22/2023Open, Classified |
| Z-1089-2023 Class II | Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b.…Sterile 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-1701-2022 Class II | Various ob/gyn packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | American Contract Systems, Inc. | 06/16/2022Open, Classified |
| Z-1005-2022 Class II | Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging…A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation… | ROi CPS LLC | 03/18/2022Terminated |
| Z-0411-2022 Class II | regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit…The kit contains a non-sterile needle. | ROi CPS LLC | 11/04/2021Terminated |
| Z-0253-2022 Class II | REGARD Newborn TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | ROi CPS LLC | 08/10/2021Terminated |
| Z-2169-2021 Class II | Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which…Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate… | ROi CPS LLC | 06/14/2021Terminated |
| Z-2168-2021 Class II | Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which…Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate… | ROi CPS LLC | 06/14/2021Terminated |
| Z-2167-2021 Class II | Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which…Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate… | ROi CPS LLC | 06/14/2021Terminated |
| Z-0524-2021 Class II | Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and…Labeling error, incorrect expiration date. | ROi CPS LLC | 10/12/2020Terminated |
| Z-2559-2015 Class II | OB PACK CS/4 Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |