JohnMark International, Inc.
JOHNMARK INTERNATIONAL, INC · Model JMI-SBTD-EYE-0002 · UDI-DI 00850011148020
Description
Mapped sterile single-use surgical back table drape which provides specific assigned delineated areas clearly marked for specific surgical items to facilitate a standardized uniform setup, order and management of the surgical back table to facilitate efficiency, instant counts and accountability of surgical instruments and items placed on the back table. Device also facilitates in training surgical technicians, scrub nurses and any surgical assist personnel to learn and adapt to a standardized methodology of surgical procedure set up and management of surgical instruments and items facilitating more efficiency, safety and positive patient outcomes.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-27 | Medline Industries, LP | Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-01-07 | Medline Industries, LP | 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 packag |
| 2026-01-07 | Medline Industries, LP | 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 packag |
| 2025-07-17 | O&M HALYARD INC | Surgical drape packs may have open seals, which may compromise the sterility of the product. |
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-11-26 | O&M HALYARD, INC. | Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. |
| 2024-09-04 | MEDLINE INDUSTRIES, LP - Northfield | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | 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 ma |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2022-12-07 | MEDLINE INDUSTRIES, LP - Northfield | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile. |
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