| | Class 2 Device Recall Medline |  |
| 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-3059-2024 |
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| Recall Event ID |
94583 |
| Product Classification |
Blood and urine collection kit (excludes HIV testing) - Product Code OIB
|
| Product | Medline Convenience kits, labeled as:
1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115;
2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044;
3) NEURO ANGIO PACK, Pack Number DYNDA1431A;
4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A;
5) LCPH LAB DRAW KIT , Pack Number DYNDH1641A ;
6) LCPH LAB DRAW KIT , Pack Number DYNDH1641AH;
7) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798;
8) BLOOD CULTURE, Pack Number DYNDH1921;
9) BLOOD WITHDRAWAL TRAY, Pack Number DYNDV1588F;
10) BLOOD WITHDRAWAL TRAY , Pack Number DYNDV1588G ;
11) PHLEBECTOMY PK, Pack Number DYNJ84749;
12) ARTHROGRAPH TRAY, Pack Number MNS12670A;
13) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915;
14) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915H ;
15) LACERATION TRAY, Pack Number SUT20955 |
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| Code Information |
BP115, Lot Number 21BBG338 ;
BP115, Lot Number 21CBE353 ;
BP115, Lot Number 21CBJ050 ;
DYLAB1044, Lot Number 23GBM782 ;
DYNDA1431A, Lot Number 2020012890;
DYNDA1683A, Lot Number 2019011790;
DYNDA1683A, Lot Number 2019032590;
DYNDA1683A, Lot Number 2019042390;
DYNDA1683A, Lot Number 2019072390;
DYNDA1683A, Lot Number 2019090990;
DYNDA1683A, Lot Number 2019102390;
DYNDA1683A, Lot Number 2019112290;
DYNDA1683A, Lot Number 2020030990;
DYNDH1641A , Lot Number 21JBE248 ;
DYNDH1641A , Lot Number 21JBY828 ;
DYNDH1641AH, Lot Number 21JBE248 ;
DYNDH1641AH, Lot Number 21JBY828 ;
DYNDH1798, Lot Number 2022112990;
DYNDH1921, Lot Number 23KBC196;
DYNDV1588F, Lot Number 2019022090;
DYNDV1588F, Lot Number 2019041890;
DYNDV1588F, Lot Number 2019090390;
DYNDV1588F, Lot Number 2020012890;
DYNDV1588G , Lot Number 22GBL908 ;
DYNDV1588G , Lot Number 22HBN586 ;
DYNDV1588G , Lot Number 22JBI927 ;
DYNDV1588G , Lot Number 22LBK218 ;
DYNDV1588G , Lot Number 23ABJ940 ;
DYNDV1588G , Lot Number 23EBB512 ;
DYNDV1588G , Lot Number 23EBU397 ;
DYNDV1588G , Lot Number 23IBU991 ;
DYNDV1588G , Lot Number 23KBS797 ;
DYNJ84749, Lot Number 23HBE651 ;
DYNJ84749, Lot Number 23JBD780 ;
MNS12670A, Lot Number 2022112990;
MNS8915, Lot Number 21GBS360 ;
MNS8915, Lot Number 21HBU417 ;
MNS8915, Lot Number 21JBI844 ;
MNS8915, Lot Number 21JBY844 ;
MNS8915, Lot Number 21LBO003 ;
MNS8915, Lot Number 21LBS501 ;
MNS8915, Lot Number 22CBY070 ;
MNS8915, Lot Number 22HBA169 ;
MNS8915, Lot Number 22HBT299 ;
MNS8915, Lot Number 22IBR400 ;
MNS8915, Lot Number 22KBV233 ;
MNS8915, Lot Number 23ABF223 ;
MNS8915, Lot Number 23CBT546 ;
MNS8915, Lot Number 23DBA141 ;
MNS8915, Lot Number 23EBF405 ;
MNS8915, Lot Number 23FBF145 ;
MNS8915, Lot Number 23GBH740 ;
MNS8915, Lot Number 23IBL050 ;
MNS8915, Lot Number 23JBK017 ;
MNS8915, Lot Number 23LBE535 ;
MNS8915, Lot Number 24ABQ710 ;
MNS8915H , Lot Number 21GBS360 ;
MNS8915H , Lot Number 21HBU417 ;
MNS8915H , Lot Number 21JBI844 ;
MNS8915H , Lot Number 21JBY844 ;
MNS8915H , Lot Number 21LBO003 ;
MNS8915H , Lot Number 21LBS501 ;
MNS8915H , Lot Number 22CBY070 ;
MNS8915H , Lot Number 22HBA169 ;
MNS8915H , Lot Number 22HBT299 ;
MNS8915H , Lot Number 22IBR400 ;
MNS8915H , Lot Number 22KBV233 ;
MNS8915H , Lot Number 23ABF223 ;
MNS8915H , Lot Number 23CBT546 ;
MNS8915H , Lot Number 23DBA141 ;
MNS8915H , Lot Number 23EBF405 ;
MNS8915H , Lot Number 23FBF145 ;
MNS8915H , Lot Number 23GBH740 ;
MNS8915H , Lot Number 23IBL050 ;
MNS8915H , Lot Number 23JBK017 ;
MNS8915H , Lot Number 23LBE535 ;
MNS8915H , Lot Number 24ABQ710 ;
SUT20955, Lot Number 2020012890 |
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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