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Class 2 Device Recall Medline O.R. Scissors |
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| Date Initiated by Firm |
May 12, 2023 |
| Date Posted |
July 20, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2206-2023 |
| Recall Event ID |
92412 |
| Product Classification |
Scissors, orthopedic, surgical - Product Code HRR
|
| Product |
Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 |
| Code Information |
Lot numbers and UDI numbers:
23BBI031, 01100801968242291023BBI031;
23BBK353, 01100801968242291023BBK353;
23BBP830, 01100801968242291023BBP830;
23BBQ676, 01100801968242291023BBQ676;
23BBR546, 01100801968242291023BBR546;
23CBH009, 01100801968242291023CBH009;
23CBL930, 01100801968242291023CBL930;
23CBP165, 01100801968242291023CBP165;
23BBS369, 01100801968242291023BBS369;
23BBT718, 01100801968242291023BBT718;
23CBV064, 01100801968242291023CBV064;
23CBW834, 01100801968242291023CBW834;
23CBV222, 01100801968242291023CBV222;
23CBW020, 01100801968242291023CBW020; and
23CBQ190, 01100801968242291023CBQ190.
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact |
Karin Johnson
886-359-1704
|
Manufacturer Reason
for Recall |
The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.
|
FDA Determined
Cause 2 |
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 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. |
| Quantity in Commerce |
189,221 scissors |
| Distribution |
US Nationwide distribution. There was government distribution but no military or foreign distribution. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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