MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-3041-2024)

Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack Number DYNDH1113; 6) ARTHROGRAM TRAY, Pack Number DYNDH1134; 7) BIOPSY TRAY, Pack Number DYNDH1137C; 8) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 9) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 10) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1275; 11) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 12) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 13) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 14) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321; 15) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324B; 16) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 17) LUMBAR TRAY, Pack Number DYNDH1500; 18) TRAY SAFETY LUMBAR PUNCTURE 18GX3.5, Pack Number DYNDH1538; 19) TRAY SAFETY LUMBAR PUNCTURE 20GX3.5, Pack Number DYNDH1539; 20) LUMBAR TRAY, Pack Number DYNDH1540; 21) LUMBAR TRAY, Pack Number DYNDH1540A; 22) BIOPSY PACK, Pack Number DYNDH1556B; 23) BIOPSY KIT, Pack Number DYNDH1570; 24) MYELOGRAM TRAY, Pack Number DYNDH1574; 25) BIOPSY BASIC PACK, Pack Number DYNDH1588; 26) BIOPSY TRAY, Pack Number DYNDH1693; 27) BIOPSY TRAY, Pack Number DYNDH1693A; 28) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1698; 29) BIOPSY PACK, Pack Number DYNDL1462B; 30) LACERATION TRAY, Pack Number DYNDL1774A; 31) LACERATION TRAY, Pack Number DYNDL1887; 32) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 33) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B; 34) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 35) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 36) MYELOGRAM TRAY W/WATER SOLUBLE, Pack Number DYNJTS04035; 37) LUMBAR TRAY, Pack Number DYNJTS0422; 38) MYELOGRAM TRAY, Pack Number DYNJTS0514; 39) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS07025; 40) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 41) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4302; 42) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 43) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 44) CENTRAL LINE INSERTION KIT W/16CM CATH, Pack Number ECVC7440A; 45) OB DELIVERY TRAY, Pack Number MNS10875; 46) OB DELIVERY TRAY, Pack Number MNS10875A; 47) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 48) BIOPSY TRAY, Pack Number P151659; 49) ARTHROGRAM PACK, Pack Number P241108; 50) ARTHROGRAM TRAY, Pack Number SPEC0004C; 51) RADIOLOGY PACK-LF, Pack Number SPEC0127; 52) ARTHROGRAM TRAY, Pack Number SPEC0143A; 53) BIOPSY TRAY, Pack Number SPEC0148; 54) RADIOLOGY/BIOPSY, Pack Number SPEC0149; 55) LUMBAR TRAY, Pack Number SPEC0177; 56) DR COPPEL FACET TRAY, Pack Number SPEC0178A; 57) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B; 58) LUMBAR TRAY, Pack Number SPEC0197D; 59) ARTHROGRAM TRAY, Pack Number SPEC0221A; 60) ARTHROGRAM TRAY, Pack Number SPEC0232; 61) 22G FACET TRAY, Pack Number SPEC0265A; 62) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289; 63) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 64) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 65) BIOPSY TRAY-LF, Pack Number SPEC4380; 66) LACERATION TRAY, Pack Number SUT18080; 67) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 68) UMBILICAL VESSEL TRAY, Pack Number UVT1100A

Class II

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.

DYNDA2063, Lot Number 2021111250; DYNDA2080, Lot Number 2019052290; DYNDA2495, Lot Number 2021040550; DYNDA2497, Lot Number 2022042650; DYNDH1113, Lot Number 2020022450; DYNDH1134, Lot Number 2021022250; DYNDH1137C, Lot Number 2021081990; DYNDH1257, Lot Number 2019120650; DYNDH1257, Lot Number 2020060550; DYNDH1257, Lot Number 2021041550; DYNDH1270, Lot Number 2019040490; DYNDH1275, Lot Number 2019022090; DYNDH1275, Lot Number 2019050990; DYNDH1275, Lot Number 2019070390; DYNDH1275, Lot Number 2019081990; DYNDH1297, Lot Number 2022041250; DYNDH1300, Lot Number 2020060550; DYNDH1300, Lot Number 2022041250; DYNDH1319, Lot Number 2020012750; DYNDH1321, Lot Number 2019032290; DYNDH1324B, Lot Number 2022032950; DYNDH1359, Lot Number 2019040490; DYNDH1500, Lot Number 2020012750; DYNDH1500, Lot Number 2022031050; DYNDH1500, Lot Number 2022032950; DYNDH1538, Lot Number 2020070850; DYNDH1539, Lot Number 2020070850; DYNDH1539, Lot Number 2022042850; DYNDH1540, Lot Number 2020080750; DYNDH1540, Lot Number 2020100250; DYNDH1540A, Lot Number 2020110950; DYNDH1540A, Lot Number 2021042250; DYNDH1540A, Lot Number 2021070750; DYNDH1540A, Lot Number 2021091850; DYNDH1540A, Lot Number 2023050190; DYNDH1540A, Lot Number 2023061390; DYNDH1556B, Lot Number 2022031050; DYNDH1570, Lot Number 2021041350; DYNDH1570, Lot Number 2022032450; DYNDH1574, Lot Number 2022031450; DYNDH1588, Lot Number 2021021750; DYNDH1693, Lot Number 2021122050; DYNDH1693A, Lot Number 2022011150; DYNDH1698, Lot Number 2022022550; DYNDH1698, Lot Number 2022031650; DYNDH1698, Lot Number 2022040550; DYNDH1698, Lot Number 2022052550; DYNDH1698, Lot Number 2022060850; DYNDL1462B, Lot Number 2022042650; DYNDL1462B, Lot Number 2022050450; DYNDL1774A, Lot Number 2019040490; DYNDL1887, Lot Number 2019101890; DYNJ05162, Lot Number 2020022450; DYNJRA0313B, Lot Number 2019040490; DYNJRA0313B, Lot Number 2019053190; DYNJRA0313B, Lot Number 2019102390; DYNJTS0018A, Lot Number 2020071050; DYNJTS0214, Lot Number 2021022250; DYNJTS04035, Lot Number 2020071050; DYNJTS0422, Lot Number 2019122750; DYNJTS0422, Lot Number 2020012350; DYNJTS0422, Lot Number 2020040850; DYNJTS0422, Lot Number 2020050850; DYNJTS0422, Lot Number 2020062550; DYNJTS0422, Lot Number 2020072350; DYNJTS0514, Lot Number 2022022250; DYNJTS07025, Lot Number 2020110450; DYNJTS07025, Lot Number 2021022250; DYNJTS07025, Lot Number 2021041550; DYNJTS07025, Lot Number 2021052450; DYNJTS07025, Lot Number 2021091850; DYNJTS07025, Lot Number 2022011150; DYNJTS07025, Lot Number 2022020750; DYNJTS07025, Lot Number 2022040650; DYNJTS4301, Lot Number 2020060550; DYNJTS4301, Lot Number 2020060550; DYNJTS4301, Lot Number 2020072250; DYNJTS4301, Lot Number 2020072250; DYNJTS4301, Lot Number 2020081950; DYNJTS4301, Lot Number 2020120450; DYNJTS4301, Lot Number 2021021750; DYNJTS4301, Lot Number 2021040550; DYNJTS4301, Lot Number 2021050250; DYNJTS4301, Lot Number 2021082550; DYNJTS4301, Lot Number 2021102250; DYNJTS4301, Lot Number 2021112250; DYNJTS4301, Lot Number 2021121750; DYNJTS4301, Lot Number 2021121750; DYNJTS4301, Lot Number 2021122050; DYNJTS4301, Lot Number 2021122050; DYNJTS4301, Lot Number 2022020350; DYNJTS4301, Lot Number 2022020350; DYNJTS4301, Lot Number 2022021850; DYNJTS4301, Lot Number 2022030250; DYNJTS4301, Lot Number 2022031450; DYNJTS4301, Lot Number 2022032450; DYNJTS4301, Lot Number 2022033050; DYNJTS4301, Lot Number 2022041250; DYNJTS4301, Lot Number 2022041350; DYNJTS4301, Lot Number 2022041350; DYNJTS4301, Lot Number 2022042650; DYNJTS4301, Lot Number 2022042550; DYNJTS4301, Lot Number 2022050450; DYNJTS4301, Lot Number 2022051850; DYNJTS4302, Lot Number 2020060850; DYNJTS4302, Lot Number 2020072250; DYNJTS4302, Lot Number 2020090250; DYNJTS4302, Lot Number 2020110250; DYNJTS4302, Lot Number 2021020950; DYNJTS4302, Lot Number 2021041350; DYNJTS4302, Lot Number 2021060150; DYNJTS4302, Lot Number 2021081950; DYNJTS4302, Lot Number 2021081950; DYNJTS4302, Lot Number 2022020250; DYNJTS4302, Lot Number 2022030650; DYNJTS4302, Lot Number 2022031450; DYNJTS4302, Lot Number 2022040650; DYNJTS4302, Lot Number 2022040650; DYNJTS4306, Lot Number 2019120650; DYNJTS4306, Lot Number 2020022450; DYNJTS4306, Lot Number 2020042250; DYNJTS4306, Lot Number 2020061150; DYNJTS4306, Lot Number 2020071050; DYNJTS4306, Lot Number 2020090250; DYNJTS4306, Lot Number 2020093050; DYNJTS4306, Lot Number 2021011950; DYNJTS4306, Lot Number 2021051350; DYNJTS4306, Lot Number 2021080650; DYNJTS4306, Lot Number 2021082750; DYNJTS4306, Lot Number 2021091850; DYNJTS4306, Lot Number 2022022250; DYNJTS8100, Lot Number 2019111450; DYNJTS8100, Lot Number 2020081850; DYNJTS8100, Lot Number 2021031750; DYNJTS8100, Lot Number 2021060250; DYNJTS8100, Lot Number 2021072750; DYNJTS8100, Lot Number 2021111250; DYNJTS8100, Lot Number 2022041850; ECVC7440A, Lot Number 2022031450; MNS10875, Lot Number 2019040890; MNS10875A, Lot Number 2021081990; MNS4815, Lot Number 2023050190; P151659, Lot Number 2019102390; P241108, Lot Number 2020072250; P241108, Lot Number 2021082550; P241108, Lot Number 2021111250; SPEC0004C, Lot Number 2019053190; SPEC0127, Lot Number 2019111880; SPEC0143A, Lot Number 2020100250; SPEC0143A, Lot Number 2021082550; SPEC0143A, Lot Number 2022011150; SPEC0148, Lot Number 2022032950; SPEC0149, Lot Number 2020100250; SPEC0177, Lot Number 2018121090; SPEC0177, Lot Number 2019040890; SPEC0177, Lot Number 2019052290; SPEC0177, Lot Number 2019091190; SPEC0177, Lot Number 2019101890; SPEC0177, Lot Number 2020021390; SPEC0177, Lot Number 2021081990; SPEC0177, Lot Number 2021091690; SPEC0178A, Lot Number 2019040890; SPEC0178A, Lot Number 2019050990; SPEC0196B, Lot Number 2019102390; SPEC0197D, Lot Number 2019111880; SPEC0197D, Lot Number 2020060180; SPEC0221A, Lot Number 2020090250; SPEC0221A, Lot Number 2022033050; SPEC0232, Lot Number 2021041550; SPEC0265A, Lot Number 2019101890; SPEC0289, Lot Number 2019050990; SPEC0289, Lot Number 2019071690; SPEC0289, Lot Number 2019092390; SPEC0289, Lot Number 2019121790; SPEC0300B, Lot Number 2022033050; SPEC0400, Lot Number 2020072250; SPEC4380, Lot Number 2021041550; SUT18080, Lot Number 2020100250; SUT18080, Lot Number 2022011150; SUT20455, Lot Number 2019040490; UVT1100A, Lot Number 2022020250; UVT1100A, Lot Number 2022022250

Worldwide distribution.

Voluntary: Firm initiated