Home / Recalls / Medicina Uk Ltd / Z-0109-2023

Z-0109-2023 Class II Ongoing

Recalled by Medicina Uk Ltd — Bolton, N/A

FDA device recall Z-0109-2023 was initiated by Medicina Uk Ltd on July 4, 2022 and is designated Class II. Reason for recall: Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification The recall status is ongoing. Affected quantity: 120 boxes (12,000 Syringes).

Recall Details

Product Type
Devices
Report Date
October 26, 2022
Initiation Date
July 4, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120 boxes (12,000 Syringes)

Product Description

Medicina Oral Tip Syringe 0.5ml Code: OT005

Reason for Recall

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Distribution Pattern

Nationwide

Code Information

UDI-DI: (01)05060278503417 Batch number: HM19024

Other recalls by Medicina Uk Ltd

  • Z-0111-2023 Class II — Medicina Oral Tip Syringe 2.5ml Code: OT25 (July 4, 2022)
  • Z-0107-2023 Class II — Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD (July 4, 2022)
  • Z-0110-2023 Class II — Medicina Oral Tip Syringe 1ml Code: OT01 (July 4, 2022)
  • Z-0113-2023 Class II — Medicina Reusable Oral syringe 5ml Code: OTH05 (July 4, 2022)
  • Z-0114-2023 Class II — Medicina Reusable Oral syringe 2.5ml Code: OTH25 (July 4, 2022)
  • Z-0112-2023 Class II — Medicina Reusable Oral syringe 1ml Code: OTH01 (July 4, 2022)
  • Z-0108-2023 Class II — Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05 (July 4, 2022)

FDA data resources