Medline Convenience Kits Recalled Over Bacillus Contamination
Medline Industries, LP is recalling 398 medical convenience kits that may be contaminated with low levels of Bacillus species. The recall affects specific SKUs distributed across multiple US states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving potential microbial contamination (Bacillus species) in medical devices. Per the rubric, FDA Class II recalls with risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Medline Industries, LP is recalling specific Medline medical convenience kits that contain BD PurPrep 26 mL, which may be contaminated with low levels of Bacillus species. The affected products are the SHOULDER PACK (SKU DYNJ39590O), SHOULDER PACK (SKU DYNJ88566), and MAJOR ORTHO KIT (SKU DYNJ911535). A total of 398 kits are included in the recall.
The recall was initiated due to the potential presence of Bacillus species contamination at low levels in the BD PurPrep 26 mL component. Bacillus species can pose a risk of infection, particularly in healthcare settings or for immunocompromised individuals.
The recalled kits were distributed to customers in the following US states: Connecticut, Florida, Kansas, Ohio, Oregon, New York, Maryland, Montana, Virginia, and Massachusetts. Specific lot numbers and UDI/DI codes are listed in the recall notice for each affected SKU.
Healthcare facilities and consumers who received the affected kits should immediately check the lot numbers and UDI/DI codes against the recall notice. Any affected products should be quarantined and returned according to the recall instructions provided by Medline Industries, LP.
The recalled product
- Product
- Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.
- Manufacturer
- Medline Industries, LP
- Affected units
- 398
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Medline Kit SKU DYNJ39590O
- UDI/DI 10198459187780 (each) 40198459187781 (case)
- Lot Number 25GBE239
- Lot Number 24LBF187
- Lot Number 25ABM992
- Lot Number 25CBJ129
- Lot Number 25DBI743
- Medline Kit SKU DYNJ88566
- UDI/DI 10198459179235 (each) 40198459179236 (case)
- Lot Number 24KBK487
- Medline Kit SKU DYNJ911535
- UDI/DI 10198459377600 (each) 40198459377601 (case)
- Lot Number 25FBU802.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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