| Class 2 Device Recall Medline | |
Date Initiated by Firm | April 08, 2024 |
Date Posted | September 06, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2981-2024 |
Recall Event ID |
94583 |
Product Classification |
Catheters, suction, tracheobronchial - Product Code BSY
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Product | Medline Convenience kits, labeled as:
1) TRACHEOTOMY TRAY, Pack Number DYNDA1894;
2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; |
Code Information |
DYNDA1894, Lot Number 2019080890;
DYNDA1894, Lot Number 2019082190;
MNS9580, Lot Number 2019080890
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Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
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For Additional Information Contact | Karin Johnson 886-359-1704 |
Manufacturer Reason for Recall | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods. |
Distribution | Worldwide 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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