MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
FDA Recall Z-2595-2023 · Posted 2023-09-18
Advertisement
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeJOK
Date Initiated2023-08-03
Product Quantity324,451 devices
Reason for Recall
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement