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Open, Classified

Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000

FDA Recall Z-2206-2023 · Posted 2023-07-20

Recall StatusOpen, Classified
Product CodeHRR
Date Initiated2023-05-12
Product Quantity189,221 scissors

Reason for Recall

The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.

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 of the recall who have received the affected product and the customer is to document the destruction of their product. The distributor is to include the customer product quantities in their response form.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution. There was government distribution but no military or foreign distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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