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
This recall is currently active, issued August 28, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- April 8, 2024
- Posted
- August 28, 2024
- Recall Number
- Z-2765-2024
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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.