Recall Z-2206-2023 ยท HRR Scissors, Orthopedic, Surgical
MEDLINE INDUSTRIES, LP - Northfield
Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
| Date | Jul 20, 2023 (initiated May 12, 2023) |
| Status | Open, Classified |
| Reason | The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated 5/12/2023 via first class mail and email on 5/12/2023. The letter explained the reason for recall and provided the required actions. The actions were to immediately check their inventory for the affected item number and lot numbers listed on the recalling firm's recall portal and destroy the products. A website link is provided for completing the response form and for obtaining the specific item and lot numbers affected. Once the response form is submitted, the consignee account will be credited. Distributors are instructed to notify the customers o |
| Quantity | 189,221 scissors |
| Distribution | US Nationwide distribution. There was government distribution but no military or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.