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Class 2 Device Recall Winged Sponges |
 |
| Date Initiated by Firm |
February 10, 2020 |
| Create Date |
March 20, 2020 |
| Recall Status1 |
Terminated 3 on February 13, 2023 |
| Recall Number |
Z-1546-2020 |
| Recall Event ID |
85022 |
| Product Classification |
General surgery tray - Product Code LRO
|
| Product |
Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153. |
| Code Information |
REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153 |
Recalling Firm/
Manufacturer |
Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
|
| For Additional Information Contact |
Benjamin Gora
866-359-1704
|
Manufacturer Reason
for Recall |
Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
|
FDA Determined
Cause 2 |
Packaging |
| Action |
Medline notified customers on February 18, 2020 via "Urgent Recall Immediate Action required" letter. The consignees were instructed to complete the response form and return the product. The recall letter identified the affected product and lot numbers. Reason for the correction was also noted in the recall letter. |
| Quantity in Commerce |
3,690 units |
| Distribution |
US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI. |
| Total Product Life Cycle |
TPLC Device Report
|
|
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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