Medline surgical kits recalled for inadequate welds in perforators
Medline is recalling surgical kits containing Codman Disposable Perforators due to inadequate welds that may cause the instruments 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: FDA Class I classification requires a minimum score of 4 per the rubric. No deaths or reported injuries have been documented, so the score is 4 rather than 5.
Plain-English summary
Medline Industries is recalling surgical kits containing Codman Disposable Perforators due to inadequate welds on specific production lots. The affected products include nine different surgical kit configurations used in craniotomy procedures (brain surgery).
Perforators with inadequate welds may break or separate during use. This defect could compromise the integrity of the surgical instrument and potentially impact patient safety during neurosurgical procedures.
The recall affects 1,853 units distributed across the United States, including California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Texas, Vermont, and Wisconsin. Medline Industries, LP, based in Northfield, is the recalling manufacturer.
Customers who have received these kits should stop use immediately and contact Medline Industries for instructions on replacement or return of the recalled products. A detailed list of affected product SKUs and lot numbers is available through the FDA.
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
- weld-defect
- equipment-failure
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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