Recall Z-0107-2023 ยท KYW Container, Liquid Medication, Graduated
Medicina Uk Ltd
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
| Date | Oct 20, 2022 (initiated Jul 4, 2022) |
| Status | Open, Classified |
| Reason | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification |
| Root cause | Nonconforming Material/Component |
| Action | Medicina Ltd issued Field Safety Corrective Action notice to the US Distributor 07/04/2022 via email. The US Distributor is conducting recall to the user level letter issued the week of July 25th via United States Postal Service. . Letter states reason for recall, health risk and action to take: Action to be taken - Please carefully read this Field Safety Notice and return the Acknowledgement Form - Please do not use any of the batches of product listed on this notice - If you have product to return, please complete the information on the Acknowledgement Form and our team will arrange the r |
| Quantity | 9 boxes (900 syringes) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.