Recall Z-2595-2023 ยท JOK Scissors, Medical, Disposable
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
| Date | Sep 18, 2023 (initiated Aug 3, 2023) |
| Status | Open, Classified |
| Reason | 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem with the device, the potential hazard, and requested the following: Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. Distributors or those who resold or transferred the product were directed to notify their customers and have them destroy any affected product. If you have any questions, please contact the Recall Department at 866-359-1704. |
| Quantity | 324,451 devices |
| Distribution | Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.