Medline Codman Craniotomy Perforators Recalled for Inadequate Welds
Medline has recalled 1,853 surgical perforators used in craniotomy procedures due to inadequate welds that may cause the device to break or separate. The affected kits were distributed across 13 US states.
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 classified this recall as Class I, which per the guidance rules establishes a minimum severity score of 4. The inadequate welds in surgical perforators used during critical craniotomy procedures pose a significant risk of device failure during surgery, though no illnesses or injuries have been reported to date.
Plain-English summary
Medline Industries has recalled 1,853 kits containing Codman Disposable Perforators (14 mm for craniotomy procedures, SKU DYNJ35349C) due to inadequate welds on specific lot numbers.
Affected kit lot numbers are 24CBJ925, 24DBT405, and 24FBO318. The perforators feature inadequate welds that may cause the device to break or separate during use.
The recalled kits were distributed in the United States to healthcare facilities in California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Texas, Vermont, Washington, and Wisconsin. No international distribution has been reported.
If you have received one of these kits, do not use the affected perforators. Contact Medline Industries or the FDA for information about replacement or return procedures.
The recalled product
- Product
- Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weld-defect
- device-breakage
- device-separation
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 (2)
- UDI-DI 10888277858060 (EA)
- 40888277858061 (CASE) KIT LOTS 24CBJ925 24DBT405 24FBO318
Distribution
Distributed in 13 states:
- CA
- FL
- IL
- IN
- KY
- MA
- MD
- MN
- NY
- TX
- VT
- WA
- WI
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