Medline Medical Device Kits Recall for Loss of 510(k) Clearance
Medline Industries is recalling certain surgical and medical kits because their 510(k) regulatory clearances for Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. About 2,609 units were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source text states only that regulatory clearances have been rescinded, with no reports of illness, injury, or harm. This is a regulatory/documentation-based recall without evidence of actual patient risk, qualifying as a moderate precautionary recall under FDA Class II classification.
Plain-English summary
Medline Industries, LP is recalling seven models of surgical and medical device kits distributed nationwide. The affected kits include craniotomy packs, extremity packs, radiology packs, and custom packs. These products contain Control Syringes, Guidewires, and/or High-Pressure Tubing components.
The recall was initiated because the 510(k) regulatory clearances for these components have been rescinded. Approximately 2,609 units were affected by this recall.
Customers who have received these kits should contact Medline Industries, LP for instructions on handling the recalled products. The recalled lot numbers and model numbers are detailed in the original FDA notice.
The recalled product
- Product
- Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ806
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- regulatory-non-compliance
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 (20)
- 1) DYNJ32841F
- UDI-DI: 10195327037796(each)
- 40195327037797(case)
- Lot Number: 24CBF407
- 2) DYNJ46069D
- UDI-DI: 10193489493184(each)
- 40193489493185(case)
- Lot Number: 24KBG704
- 3) DYNJ51935A
- UDI-DI: 10889942735549(each)
- 40889942735540(case)
- Lot Number: 24BME364
- 4) DYNJ68902A
- UDI-DI: 10193489870411(each)
- 40193489870412(case)
- Lot Number: 24BMC999
- 5) DYNJ80679A
- UDI-DI: 10195327273705(each)
- 40195327273706(case)
- Lot Number: 22KBJ690
Distribution
Distributed nationwide across the United States.
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