Medline Surgical Kits with Codman Disposable Perforator recalled
Medline surgical kits containing Codman Disposable Perforators are being recalled because certain lots have inadequate welds that may cause the perforator to break or separate during use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class I, which carries a mandatory minimum severity of 4 per the rubric. A device defect that could cause failure during neurosurgery—breakage or separation of a perforator—poses significant risk of serious injury.
Plain-English summary
Medline Industries, LP is recalling surgical kits that contain Codman Disposable Perforators due to inadequate welds on specific lots. The affected kits are: 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). A total of 1,853 units were distributed to hospitals and medical facilities in CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA, and WI.
Perforators with inadequate welds may break or separate during use. The specific lot numbers and UDI codes are detailed in the recall notice and should be checked before use.
Healthcare facilities that received these kits should stop using affected lots immediately and contact Medline or the FDA with questions about this recall.
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
- Affected units
- 1,853
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
Part of a larger recall action
This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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