| | 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-2765-2024 |
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| Recall Event ID |
94581 |
| Product Classification |
Orthopedic tray - Product Code OJH
|
| Product | Medline procedural kits labeled as:
1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ;
2) ANTERIOR HIP PACK , Pack Number DYNJ82317;
3) ARTHROGRAM, Pack Number DYNDH1446A ;
4) ARTHROGRAM TRAY, Pack Number DYNDH1648;
5) ARTHROGRAM TRAY, Pack Number PAIN1396 ;
6) ARTHROGRAM TRAY , Pack Number DYNDH1648;
7) ARTHROGRAM TRAY , Pack Number PAIN1396 ;
8) ARTHROGRAM/ASPIRATION RADIOLOG, Pack Number DYNJRA2152 ;
9) ARTHROGRAPH TRAY, Pack Number MNS12670B;
10) ARTHROSCOPY , Pack Number DYNJ909699 ;
11) GLMI ARTHROGRAM KIT: BIG TREE , Pack Number DYNDH1752;
12) HANA TABLE, Pack Number DYNJ908424A;
13) JC HIP ARTHROSCOPY, Pack Number DYNJ907481 ;
14) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480 ;
15) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480A;
16) JC SHOULDER ARTHROSCOPY , Pack Number DYNJ907479A;
17) LUMBAR DRAIN PACK , Pack Number DYNJ67379;
18) LUMBAR DRAIN PACK , Pack Number DYNJ67379H ;
19) OPEN SHOULDER CDS , Pack Number CDS983316D ;
20) ORTHO SPINE PACK, Pack Number DYNJ59720A ;
21) ORTHO SPINE PACK, Pack Number DYNJ59720B ;
22) PODIATRY TRAY-LF, Pack Number DYNJ51178D ;
23) TOTAL KNEE CDS-LF , Pack Number CDS940845L ;
24) TOTAL KNEE CDS-LF , Pack Number DYNJ907028 ;
25) TOTAL KNEE CDS-LF , Pack Number DYNJ907028A;
26) TOTAL KNEE CDS-LF , Pack Number DYNJ907028C |
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| Code Information |
DYNJ63330B , Lot Number: 23KMB339 ;
DYNJ82317, Lot Number: 23JMD184 ;
DYNDH1446A , Lot Number: 21LBY820 ;
DYNDH1446A , Lot Number: 22GBD333 ;
DYNDH1446A , Lot Number: 22JBR587 ;
DYNDH1446A , Lot Number: 23FBP838 ;
DYNDH1446A , Lot Number: 23GBR825 ;
DYNDH1446A , Lot Number: 23HBU128 ;
DYNDH1446A , Lot Number: 23IBD510 ;
DYNDH1446A , Lot Number: 23JBY402 ;
DYNDH1446A , Lot Number: 24ABN001 ;
DYNDH1446A , Lot Number: 24BBU148 ;
DYNDH1446A , Lot Number: 21BBP451 ;
DYNDH1446A , Lot Number: 21BBQ361 ;
DYNDH1648, Lot Number: 24CBI888 ;
PAIN1396 , Lot Number: 24CMC928 ;
DYNDH1648, Lot Number: 23BBU844 ;
DYNDH1648, Lot Number: 23FBT610 ;
DYNDH1648, Lot Number: 23KBG110 ;
DYNDH1648, Lot Number: 23LBH307 ;
DYNDH1648, Lot Number: 24BBQ373 ;
PAIN1396 , Lot Number: 21HBQ984 ;
PAIN1396 , Lot Number: 21LBQ751 ;
PAIN1396 , Lot Number: 22BBY990 ;
PAIN1396 , Lot Number: 22EBO906 ;
PAIN1396 , Lot Number: 22GMH098 ;
PAIN1396 , Lot Number: 22JMC249 ;
PAIN1396 , Lot Number: 23AMC516 ;
DYNJRA2152 , Lot Number: 23FBO275 ;
DYNJRA2152 , Lot Number: 24BBP039 ;
MNS12670B, Lot Number: 21FBO557 ;
DYNJ909699 , Lot Number: 23IBG223 ;
DYNJ909699 , Lot Number: 23IBI956 ;
DYNDH1752, Lot Number: 22HLA308 ;
DYNDH1752, Lot Number: 22KLA526 ;
DYNDH1752, Lot Number: 23ELA116 ;
DYNDH1752, Lot Number: 23FLA891 ;
DYNDH1752, Lot Number: 23HLA148 ;
DYNDH1752, Lot Number: 23JLA566 ;
DYNJ908424A, Lot Number: 23IBP270 ;
DYNJ907481 , Lot Number: 22CBZ144 ;
DYNJ907481 , Lot Number: 22JBR781 ;
DYNJ907480 , Lot Number: 21LBR978 ;
DYNJ907480A, Lot Number: 22GBS401 ;
DYNJ907480A, Lot Number: 22HBS464 ;
DYNJ907480A, Lot Number: 22KBO665 ;
DYNJ907480A, Lot Number: 22LBM801 ;
DYNJ907480A, Lot Number: 23ABS425 ;
DYNJ907480A, Lot Number: 23BBN787 ;
DYNJ907480A, Lot Number: 23JBR354 ;
DYNJ907480A, Lot Number: 24ABJ482 ;
DYNJ907479A, Lot Number: 22EBM144 ;
DYNJ907479A, Lot Number: 22EBN033 ;
DYNJ67379, Lot Number: 22OBA461 ;
DYNJ67379H , Lot Number: 22OBA461 ;
CDS983316D , Lot Number: 21KBZ646 ;
CDS983316D , Lot Number: 22GBK913 ;
CDS983316D , Lot Number: 22JBP359 ;
CDS983316D , Lot Number: 22JBQ356 ;
DYNJ59720A , Lot Number: 21LBL971 ;
DYNJ59720B , Lot Number: 22GBE154 ;
DYNJ59720B , Lot Number: 22HBY469 ;
DYNJ59720B , Lot Number: 23FBQ399 ;
DYNJ59720B , Lot Number: 23IBL648 ;
DYNJ51178D , Lot Number: 23IDA216 ;
CDS940845L , Lot Number: 21LBG348 ;
CDS940845L , Lot Number: 22GBJ055 ;
CDS940845L , Lot Number: 22GBJ056 ;
CDS940845L , Lot Number: 22KBH989 ;
CDS940845L , Lot Number: 22KBJ721 ;
CDS940845L , Lot Number: 22KBJ722 ;
DYNJ907028 , Lot Number: 21KBV769 ;
DYNJ907028 , Lot Number: 21LBG283 ;
DYNJ907028A, Lot Number: 22HBS848 ;
DYNJ907028C, Lot Number: 23BBN541 ;
DYNJ907028C, Lot Number: 23CBO748 ;
DYNJ907028C, Lot Number: 23GBC293 ;
DYNJ907028C, Lot Number: 23IBD257 ;
DYNJ907028C, Lot Number: 23IBV462 |
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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