Monoject Sterile M200 Aluminum/M250 Polypropylene

• • Terminated Z-0424-2021 FDA Class II ·initiated 25 Sep 2020

  Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle

• 17 recalls, same reason

  • Completed Z-2050-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2049-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2042-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2052-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2048-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2043-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2044-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2040-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2047-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2051-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2037-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2039-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2041-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2045-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2046-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2036-2019 FDA Class II ·initiated 30 Apr 2019
  • Completed Z-2038-2019 FDA Class II ·initiated 30 Apr 2019

  Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

510(k) Number

K854547 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Labcer Fibrinogen Assay Kit & Calibr.

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• Monoject(R) Trace Element Blood Collection Tube

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• Monoject Samplette Amber Capillary Serum Separator

  Class I

  FDA 510(k) K875061 Active Cleared 12 Jan 1988

• Argyle Turkel Safety Trocar Thoracic Catheter

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  FDA 510(k) K933510 Active Cleared 24 Feb 1994

See all devices from Sherwood Medical Co. →