Medline Industries, LP: Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYN

Company / brand

Medline Industries, LP

Product

Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X; 3) TOTAL HIP PACK, Kit SKU DYNJ04809N; 4) MAIN/LAMINECTOMY PACK-LF, Kit SKU DYNJ0565499AN; 5) SCC/SPOC HAND & FOOT PACK, Kit SKU DYNJ27164Q; 6) ORTHO SPINE, Kit SKU DYNJ40221G; 7) URO GYN PACK, Kit SKU DYNJ45311J; 8) LAMINECTOMY PACK, Kit SKU DYNJ46330C; 9) DJ ORTHO SPINE, Kit SKU DYNJ48980M; 10) CERVICAL PACK, Kit SKU DYNJ52995F; 11) NORTH BACK FUSION PACK-LF, Kit SKU DYNJ56483L; 12) KNEE ARTHROSCOPY CHRISTUS, Kit SKU DYNJ61200B; 13) KNEE ARTHROSCOPY PACK-LF, Kit SKU DYNJ66150; 14) HIP PACK, Kit SKU DYNJ66630; 15) OHNS FREE FLAP A PACK, Kit SKU DYNJ69065F; 16) LUMBAR PACK, Kit SKU DYNJ69113C; 17) LAMINECTOMY PACK, Kit SKU DYNJ69401D; 18) LAMINECTOMY PACK, Kit SKU DYNJ81013D; 19) HIP/SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ84275A; 20) FLASC ACL PACK, Kit SKU DYNJ88971; 21) SPINE PACK MERCY GALENA, Kit SKU DYNJ89943; 22) SPINAL FUSION MT CARMEL, Kit SKU DYNJ900173J; 23) HAND, Kit SKU DYNJ904945G; 24) LAMINECTOMY, Kit SKU DYNJ909505D; 25) SHOULDER SPLIT, Kit SKU DYNJ910543F; 26) SHOULDER SPLIT, Kit SKU DYNJ910543G; 27) CRANIOTOMY PACK, Kit SKU DYNJT4724; 28) SPINE PACK, Kit SKU DYNJT5184.

Reason / hazard

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

Classification

Class II

Status

Ongoing

Distribution / sold at

US Nationwide distribution.

Recall initiated

2025-12-12

Code info

Medline Kit SKU DYNJ0275635M: UDI/DI 10198459464799 (EA) 40198459464790 (CS), Lot Number 25KMH120; Medline Kit SKU DYNJ0395037X: UDI/DI 10198459600555 (EA) 40198459600556 (CS), Lot Number 25LMB119; Medline Kit SKU DYNJ04809N: UDI/DI 10198459440908 (EA) 40198459440909 (CS), Lot Number 25KMF969; Medline Kit SKU DYNJ0565499AN: UDI/DI 10195327318352 (EA) 40195327318353 (CS), Lot Number 25JMF339; Medline Kit SKU DYNJ0565499AN: UDI/DI 10195327318352 (EA) 40195327318353 (CS), Lot Number 25LMB019; Medline Kit SKU DYNJ27164Q: UDI/DI 10198459138102 (EA) 40198459138103 (CS), Lot Number 25KMJ742; Medline Kit SKU DYNJ40221G: UDI/DI 10198459448515 (EA) 40198459448516 (CS), Lot Number 25KME669; Medline Kit SKU DYNJ45311J: UDI/DI 10198459255670 (EA) 40198459255671 (CS), Lot Number 25KMI080; Medline Kit SKU DYNJ46330C: UDI/DI 10889942490066 (EA) 40889942490067 (CS), Lot Number 25KMD795; Medline Kit SKU DYNJ48980M: UDI/DI 10195327533694 (EA) 40195327533695 (CS), Lot Number 25KMC459; Medline Kit SKU DYNJ52995F: UDI/DI 10195327639778 (EA) 40195327639779 (CS), Lot Number 25KME064; Medline Kit SKU DYNJ56483L: UDI/DI 10195327518141 (EA) 40195327518142 (CS), Lot Number 25LMB049; Medline Kit SKU DYNJ61200B: UDI/DI 10195327604264 (EA) 40195327604265 (CS), Lot Number 25KBE867; Medline Kit SKU DYNJ66150: UDI/DI 10193489317558 (EA) 40193489317559 (CS), Lot Number 25KMC057; Medline Kit SKU DYNJ66630: UDI/DI 10193489368284 (EA) 40193489368285 (CS), Lot Number 25KMG435; Medline Kit SKU DYNJ69065F: UDI/DI 10198459226618 (EA) 40198459226619 (CS), Lot Number 25KMI293; Medline Kit SKU DYNJ69113C: UDI/DI 10198459170225 (EA) 40198459170226 (CS), Lot Number 25JMJ726; Medline Kit SKU DYNJ69401D: UDI/DI 10198459183676 (EA) 40198459183677 (CS), Lot Number 25KMJ106; Medline Kit SKU DYNJ81013D: UDI/DI 10198459547706 (EA) 40198459547707 (CS), Lot Number 25LDA122; Medline Kit SKU DYNJ84275A: UDI/DI 10198459240171 (EA) 40198459240172 (CS), Lot Number 25LMB546; Medline Kit SKU DYNJ88971: UDI/DI 10198459222269 (EA) 40198459222260 (CS), Lot Number 25KMH340; Medline Kit SKU DYNJ89943: UDI/DI 10198459299483 (EA) 40198459299484 (CS), Lot Number 25KMB583; Medline Kit SKU DYNJ900173J: UDI/DI 10198459292170 (EA) 40198459292171 (CS), Lot Number 25JDB487; Medline Kit SKU DYNJ904945G: UDI/DI 10198459518317 (EA) 40198459518318 (CS), Lot Number 25LBC198; Medline Kit SKU DYNJ909505D: UDI/DI 10198459594229 (EA) 40198459594220 (CS), Lot Number 25LMB637; Medline Kit SKU DYNJ910543F: UDI/DI 10198459554971 (EA) 40198459554972 (CS), Lot Number 25KMH376; Medline Kit SKU DYNJ910543G: UDI/DI 10198459588204 (EA) 40198459588205 (CS), Lot Number 25LMA619; Medline Kit SKU DYNJT4724: UDI/DI 10198459457913 (EA) 40198459457914 (CS), Lot Number 25KMI923; Medline Kit SKU DYNJT5184: UDI/DI 10198459467592 (EA) 40198459467593 (CS), Lot Number 25KMG240.

Product quantity

117 units

Voluntary mandated

Voluntary: Firm initiated

City

Northfield

State

IL

Country

United States

Event id

98226

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