| Date Initiated by Firm | April 08, 2024 |
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| Date Posted | September 06, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2986-2024 |
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| Recall Event ID |
94583 |
| Product Classification |
Custom anesthesia tray - Product Code OGD
|
| Product | Medline Convenience kits labeled as:
1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ;
2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ;
3) CARDIAC MINOR-LF, Pack Number DYNJ51939;
4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573;
5) PEDIATRIC EP PACKMHS, Pack Number DYNJ58876A |
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| Code Information |
DYNDM1076A . Lot Number 19CBP748 ;
DYNDM1076A . Lot Number 19DBH317 ;
DYNDM1076A . Lot Number 19FBT944 ;
DYNJ45158A . Lot Number 21KBK059 ;
DYNJ45158A . Lot Number 21LBB289 ;
DYNJ45158A . Lot Number 19ABZ159 ;
DYNJ45158A . Lot Number 22DBS953 ;
DYNJ45158A . Lot Number 22GBC899 ;
DYNJ45158A . Lot Number 22GBE801 ;
DYNJ45158A . Lot Number 19FBG969 ;
DYNJ45158A . Lot Number 19FBM779 ;
DYNJ45158A . Lot Number 19GBS210 ;
DYNJ45158A . Lot Number 19HBS882 ;
DYNJ45158A . Lot Number 19IBN282 ;
DYNJ45158A . Lot Number 19JBB002 ;
DYNJ45158A . Lot Number 23ABR333 ;
DYNJ45158A . Lot Number 23CBK931 ;
DYNJ45158A . Lot Number 23HBJ279 ;
DYNJ45158A . Lot Number 23IBF733 ;
DYNJ45158A . Lot Number 20HBR669 ;
DYNJ45158A . Lot Number 20HBX586 ;
DYNJ45158A . Lot Number 20LBZ104 ;
DYNJ45158A . Lot Number 21EBP316 ;
DYNJ51939. Lot Number 22CBA086 ;
DYNJ51939. Lot Number 19ABY439 ;
DYNJ51939. Lot Number 22OBI663 ;
DYNJ51939. Lot Number 19HBH583 ;
DYNJ51939. Lot Number 19IBU567 ;
DYNJ51939. Lot Number 19JBW741 ;
DYNJ51939. Lot Number 19JBX646 ;
DYNJ51939. Lot Number 20FBT320 ;
DYNJ51939. Lot Number 20LBF765 ;
DYNJ51939. Lot Number 20LBK574 ;
DYNJ56573. Lot Number 19ABN855 ;
DYNJ56573. Lot Number 19CBF516 ;
DYNJ56573. Lot Number 19EBQ417 ;
DYNJ56573. Lot Number 19HBP237 ;
DYNJ56573. Lot Number 19UBC593 ;
DYNJ56573. Lot Number 19VBA937 ;
DYNJ56573. Lot Number 19KBB135 ;
DYNJ58876A . Lot Number 20HBW903 ;
DYNJ58876A . Lot Number 20IBJ399 ;
DYNJ58876A . Lot Number 20IBM299 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
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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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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. |
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| Distribution | Worldwide distribution. |
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| 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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