| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
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| Date Posted | August 28, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2761-2024 |
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| Recall Event ID |
94581 |
| Product Classification |
Circumcision tray - Product Code OHG
|
| Product | Medline Procedure kits labeled as:
1) CIRCUMCISION SET, Pack Number CIT6335;
2) CIRCUMCISION TRAY , Pack Number CIT6135BH;
3) CIRCUMCISION TRAY , Pack Number CIT2465;
4) CIRCUMCISION TRAY , Pack Number CIT4920;
5) CIRCUMCISION TRAY , Pack Number CIT7455;
6) CIRCUMCISION TRAY , Pack Number DYNDA3045;
7) CIRCUMCISION TRAY , Pack Number DYNDL1889;
8) CIRCUMCISION TRAY , Pack Number CIT7455H ;
9) CIRCUMCISION TRAY W/1.3 CLAMP , Pack Number CIT6075;
10) CIRCUMCISON TRAY, Pack Number CIT7380;
11) HOSPITAL CIRCUMCISION T, Pack Number CIT2825;
12) CIRCUMCISION TRAY , Pack Number CIT6135A ;
13) CIRCUMCISION TRAY , Pack Number CIT6135B ;
14) NICU CIRCUMCISION SET, Pack Number CIT6900; |
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| Code Information |
CIT6335, Lot Number 22IBT528 ;
CIT6135BH, Lot Number 22OBI417 ;
CIT6135BH, Lot Number 22FBX794 ;
CIT6135BH, Lot Number 23CBQ475 ;
CIT6135BH, Lot Number 23CBT677 ;
CIT6135BH, Lot Number 23EBP345 ;
CIT6135BH, Lot Number 23LBI785 ;
CIT6135BH, Lot Number 24BBT038 ;
CIT2465, Lot Number 21BBH212 ;
CIT4920, Lot Number 22GBS036 ;
CIT4920, Lot Number 22IBF469 ;
CIT4920, Lot Number 23CBG366 ;
CIT4920, Lot Number 23IBL492 ;
CIT7455, Lot Number 23GBV732 ;
DYNDA3045, Lot Number 23FBO420 ;
DYNDA3045, Lot Number 23GBI869 ;
DYNDA3045, Lot Number 23IBR354 ;
DYNDL1889, Lot Number 23GLB117 ;
DYNDL1889, Lot Number 23ILA455 ;
CIT7455H , Lot Number 23GBV732 ;
CIT6075, Lot Number 22DBD285 ;
CIT6075, Lot Number 22EBV624 ;
CIT6075, Lot Number 23ABM531 ;
CIT6075, Lot Number 23CBC554 ;
CIT6075, Lot Number 23CBH405 ;
CIT6075, Lot Number 23EBC481 ;
CIT6075, Lot Number 23EBS480 ;
CIT6075, Lot Number 23FBT595 ;
CIT6075, Lot Number 23IBT726 ;
CIT7380, Lot Number 22GBM440 ;
CIT7380, Lot Number 24BBM689 ;
CIT2825, Lot Number 22JBI550 ;
CIT2825, Lot Number 23BBR929 ;
CIT2825, Lot Number 23GBD786 ;
CIT2825, Lot Number 23IBL941 ;
CIT6135A , Lot Number 21CBG443 ;
CIT6135A , Lot Number 21CBG766 ;
CIT6135B , Lot Number 22OBI417 ;
CIT6135B , Lot Number 22FBX794 ;
CIT6135B , Lot Number 23CBQ475 ;
CIT6135B , Lot Number 23CBT677 ;
CIT6135B , Lot Number 23EBP345 ;
CIT6135B , Lot Number 23LBI785 ;
CIT6135B , Lot Number 24BBT038 ;
CIT6900, Lot Number 21LBB097 ;
CIT6900, Lot Number 22GBF169 ;
CIT6900, Lot Number 22IBR336 ;
CIT6900, Lot Number 23DBE643 |
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 the 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 |
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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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