Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pa

Summary

The FDA issued a Class II for Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue.

Details

Product Description

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

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

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-04-08

Company