Medline surgical convenience kits recalled for potential Bacillus contamination
Medline Industries is recalling nine types of surgical convenience kits that contain BD PurPrep solution. The solution may be contaminated with low levels of Bacillus species, a bacterium that could pose a risk if the kits are used in sterile procedures. The recall affects specific lot numbers of joint, spine, and neurological surgery kits distributed to hospitals and surgical centers in ten U.S. states.
From the FDA notice · Read the official notice ↗ · All Medline recalls
What to do
- Check if your facility has any of the affected Medline kit SKUs listed in this recall.
- Do not use kits with the affected lot numbers.
- Contact Medline Industries or your supplier for instructions on returning affected kits.
- Review your records to identify which patients may have received care with affected kits.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
- Made for
- All ages (0 months and older)
This recall covers 4 products — see all of them.
Details
- Units affected
- 1601 units
- Illnesses reported
- None reported
- Manufactured in
- 3 Lakes Dr, N/A, Northfield, IL, United States
- Classification
- Class II
- Recall number
- Z-2791-2026
In the FDA's words
- Description
- 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. 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. Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 24KMI926; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25BMI009; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25DME458; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25FMC143; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24KME109; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24LMD416; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25BMB162; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMB403; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMK347; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25FMA695; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABJ808; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABM644; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25BBT262; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 24LBD661; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25ABP134; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25BBS412; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25DBS673; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25FBS372; Medline Kit SKU DYNJ907984C, UDI/DI 10198459130977 (each) 40198459130978 (case), Lot Number 25CBO351; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 24LBO744; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25ABD265; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBD596; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBO352; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBB260; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBV317; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25EBD582; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25FBM835; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBC117; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBE196; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25FBL400; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBD222; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBN441; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25ABL748; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25EBF179; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25FBF363. Distribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA. Affected quantity: 1601 units
- 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.
4 products in this recall
Medline convenience kits with BD PurPrep recalled for Bacillus risk
Medline is recalling specific medical convenience kits that include BD PurPrep 26 mL antiseptic skin prep. The prep may contain low levels of Bacillus bacteria. The recall covers four product listings, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910…Z-2788-2026 · 155 kits
- Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO…Z-2789-2026 · 398 kits
- Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397PZ-2790-2026 · 574 kits
- Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANT… (this page)Z-2791-2026 · 1601 units
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