Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PA
Summary
The FDA issued a Class I for Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESS by MEDLINE INDUSTRIES, LP - Northfield. Reason: Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequat.
Details
Source
Device Recall
External ID
Z-1811-2025
Action Date
2025-06-11
Status
Ongoing
Category
device
Product Description
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 DYNJVB91001A 5. CRANIOTOMY CDS SKU CDS981888X CDS983467I 6. CRANIOTOMY PACK-LF SKU DYNJ09882G DYNJ09882I 7. CRANIOTOMY S NASSAU SKU DYNJ905879G 8. MHC CRANIOTOMY SKU DYNJ903713K DYNJ903713L 9. PAD CRANIOTOMY SKU DYNJ902149J
Lot/Code Info: 1. CRANI ACCESSORY PACK SKU DYNJ59270 UDI-DI 10888277771512 (ea), 40888277771513 (case) Lots 23JDB683 23JDC548 24ADB783 24HDA822 2. CRANI PACK-LF SKU DYNJ44805M UDI-DI 10195327506872 (ea), 40195327506873 (case) Lots 23JBI747 23KBL228 24ABG696 24CBM117 24EBQ114 24GBJ699 3. CRANIOTOMY SKU CDS982719V UDI-DI 10195327510831 (ea), 40195327510832 (case) Lots 23KBP461 23LBN381 24ABB119 24BBC547 24BBI145 SKU CDS982719W UDI-DI 10195327645090 (ea), 40195327645091 (case) Lots 24DBS813 SKU DYNJ904168F UDI-DI 10195327395728 (ea), 40195327395729 (case) Lots 24DBU188 SKU DYNJ908404B UDI-DI 10195327410506 (ea), 40195327410507 (case) Lots 23IDB680 23LDB546 24BDB174 24FDA741 24FDB584 24IDA225 24IDA646 24IDA840 SKU DYNJ908723A UDI-DI 10195327403270 (ea), 40195327403271 (case) Lots 23IBO314 23JBC218 24ABK090 SKU DYNJ908723C UDI-DI 10198459009785 (ea), 40198459009786 (case) Lots 24IBM205 24IBN365 25ABM356 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A UDI-DI 10195327466466 (ea), 40195327466467 (case) Lots 23JLA765 24DLA724 24DLB006 24ELA325 5. CRANIOTOMY CDS SKU CDS981888X UDI-DI 10195327144760 (ea), 40195327144761 (case) Lots 24ABT432 24CBD698 24HBH954 24HBP483 24IBG797 25CBF098 SKU CDS983467I UDI-DI 10195327457945 (ea), 40195327457946 (case) Lots 23KDA336 6. CRANIOTOMY PACK-LF SKU DYNJ09882G UDI-DI 10195327574055 (ea), 40195327574056 (case) Lots 24CBF778 SKU DYNJ09882I UDI-DI 10198459058172 (ea), 40198459058173 (case) Lots 24HBN426 7. CRANIOTOMY S NASSAU SKU DYNJ905879G UDI-DI 10195327512996 (ea), 40195327512997 (case) Lots 23KBI086 23LBH647 23LBH649 24BBU253 24DBV133 24FBE409 8. MHC CRANIOTOMY SKU DYNJ903713K UDI-DI 10195327201579 (ea), 40195327201570 (case) Lots 23JBK426 SKU DYNJ903713L UDI-DI 10195327531218 (ea), 40195327531219 (case) Lots 23KBT939 23LBS862 24ABH577 24CBH126 24CBH771 9. PAD CRANIOTOMY SKU DYNJ902149J UDI-DI 10195327554323 (ea), 40195327554324 (case) Lots 23KBP275 24ABJ684 24CBF216 24DBI296 24EBD959 24FBF064 24HBK164 24IBN443
Quantity Affected: 1,853 total
Reason for Recall
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Distribution
US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-22
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 165 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1811-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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