Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B: 4) LAMINECTOMY-SMH Medline Kit SKU DYNJ907732C: 5) KYPHOPLASTY Medline Kit SKU DYNJ907984C: 6) LUMBAR
Medline Industries, LP
The hazard
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B: 4) LAMINECTOMY-SMH Medline Kit SKU DYNJ907732C: 5) KYPHOPLASTY Medline Kit SKU DYNJ907984C: 6) LUMBAR LAMINECTOMY Medline Kit SKU DYNJ907987D: 7) KYPHOPLASTY TRAY Medline Kit SKU DYNJ908413C: 8) CRANIOTOMY Medline Kit SKU DYNJ910626: 9) NEURO SPINE Medline Kit SKU DYNJ910639.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Medline Kit SKU DYNJ65065AModel UDI/DI 10193489317244 (each) 40193489317245 (case)Model Lot Number 24KMI926Model Lot Number 25BMI009Model Lot Number 25DME458Model Lot Number 25FMC143Model Medline Kit SKU DYNJ65066BModel UDI/DI 10193489317183 (each) 40193489317184 (case)Model Lot Number 24KME109Model Lot Number 24LMD416Model Lot Number 25BMB162Model Lot Number 25DMB403UPC 10193489317244UPC 40193489317245UPC 10193489317183UPC 40193489317184UPC 10195327671808UPC 40195327671809Would you have heard about this one?
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