Medline surgical kits recalled for faulty perforator welds
Medline is recalling surgical kits containing Codman Disposable Perforators due to inadequate welds on specific lots. Affected perforators may break or separate during craniotomy procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification represents the agency's most serious category of medical device recall. Although no injuries or deaths have been reported, the defect in surgical instruments used during critical neurosurgical procedures represents significant risk and meets the minimum threshold for Severe severity.
Plain-English summary
Medline Industries is recalling multiple surgical kit sets that contain Codman Disposable Perforators (14 mm). The recalled kits include: CRANI ADD A PACK (SKU DYNJ30926O), CRANIOTOMY (SKU CDS983611N), CRANIOTOMY CDS (SKU CDS983467J), CRANIOTOMY PACK (SKU DYNJ85807A and DYNJ85927), and MAJOR CRANIOTOMY PACK (SKU DYNJ82007A).
The perforators in affected lots have inadequate welds, which may cause them to break or separate during surgical use. This creates a risk of device failure during craniotomy procedures.
Approximately 1,853 units were distributed to medical facilities across the United States, including in California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Texas, Vermont, Washington, and Wisconsin.
Healthcare providers should refer to the FDA recall notice for specific lot numbers, UDI codes, and further instructions regarding these products.
The recalled product
- Product
- Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weld-failure
- device-breakage
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 (17)
- 1. CRANI ADD A PACK
- SKU DYNJ30926O
- UDI-DI 10195327539153 (EA)
- 40195327539154 (CASE) KIT LOTS 24AMF811 2. CRANIOTOMY
- SKU CDS983611N
- UDI-DI 10195327466626 (EA)
- 40195327466627 (CASE) KIT LOTS 23KBA720 23LBI611 23LBJ586 3. CRANIOTOMY CDS
- SKU CDS983467J
- UDI-DI 10195327561116 (EA)
- SKU DYNJ85807A
- UDI-DI 10195327637392 (EA)
- 40195327637393 (CASE) KIT LOTS 24CBB843 24EBC889 24GBY029
- SKU DYNJ85927
- UDI-DI 10195327575571 (EA)
- 40195327575572 (CASE) KIT LOTS 24BMD310 24EMI836 5. MAJOR CRANIOTOMY PACK
- SKU DYNJ82007A UDI-DI 10195327635466 (EA)
- 40195327635467 (CASE) KIT LOTS 24CMA496 24HMI081 24HMI978
Distribution
Distributed in 13 states:
- CA
- FL
- IL
- IN
- KY
- MA
- MD
- MN
- NY
- TX
- VT
- WA
- WI
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