Medline Craniotomy Kits with Defective Codman Disposable Perforators Recalled
Medline is recalling multiple craniotomy kits containing Codman Disposable Perforators due to inadequate welds that may cause the perforators to break or separate during use.
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: This is an FDA Class I recall of a medical device used in cranial surgery. Although no reported injuries or fatalities are stated in the source, Class I designation by the FDA indicates a serious risk of adverse health consequences; a device failure during neurosurgery poses significant patient harm potential.
Plain-English summary
Medline Industries, LP is recalling nine types of craniotomy kits that contain recalled Integra Lifesciences Codman Disposable Perforators. The affected kits include CRANI ACCESSORY PACK, CRANI PACK-LF, CRANIOTOMY, CRANIOTOMY #IMF, CRANIOTOMY CDS, CRANIOTOMY PACK-LF, CRANIOTOMY S NASSAU, MHC CRANIOTOMY, and PAD CRANIOTOMY. A total of 1,853 units were distributed in the United States to California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Texas, Vermont, Washington, and Wisconsin.
The perforators have inadequate welds on specific lots. Perforators with inadequate welds may break or separate during use, which could compromise the safety and effectiveness of the surgical procedure. Specific lot numbers, SKUs, and UDI codes are listed in the FDA recall notice.
Affected kits should not be used. Healthcare facilities and individuals in possession of these kits should stop using them immediately and contact the manufacturer or healthcare provider for instructions on returns or replacement.
The recalled product
- Product
- Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYN
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- device-failure
- weld-defect
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 (5)
- 1. CRANI ACCESSORY PACK SKU DYNJ59270 UDI-DI 10888277771512 (ea)
- 40195327645091 (case) Lots 24DBS813 SKU DYNJ904168F UDI-DI 10195327395728 (ea)
- 40195327395729 (case) Lots 24DBU188 SKU DYNJ908404B UDI-DI 10195327410506 (ea)
- 40195327574056 (case) Lots 24CBF778 SKU DYNJ09882I UDI-DI 10198459058172 (ea)
- 40195327201570 (case) Lots 23JBK426 SKU DYNJ903713L UDI-DI 10195327531218 (ea)
Distribution
Distributed in 13 states:
- CA
- FL
- IL
- IN
- KY
- MA
- MD
- MN
- NY
- TX
- VT
- WA
- WI
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