Devices

CRANIOTOMY PACK

Model / Serial
Catalog number CPA-2382 Lot numbers 000000344, 000000612, 000001469, 000002199, 000003462, 000003952, 000004570, 000005078, 000005597, 000005879, 000005852, 000006499, 000006505
Distribution
The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
Product Description
CRANIOTOMY PACK
Manufacturer
Windstone Medical, Inc.
1 Event
- Recall of CRANIOTOMY PACK

Manufacturer

Windstone Medical, Inc.

Manufacturer Address
Windstone Medical, Inc., 1602 4th Ave North, Billings MT 59101
Source
USFDA

4 devices with a similar name

Learn more about the data here

Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK

Model / Serial
REF 89-7639.01 - Lot Number 24579045 REF 89-7639.01 - Lot Number 24664258 REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
(USA) including Indiana
Product Description
Custom surgical kits: || DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || surgical kits
Manufacturer
DeRoyal Processing Center

CUSTOM STERILE CRANIOTOMY PACK

Model / Serial
Model Catalog: SNE30PCXXX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SNE30CRXXX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SBA30TF'XXX' (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SBA30FF'XXX' (Lot serial: >10 NUMBERS CONTACT MFG)
Product Description
CUSTOM STERILE CRANIOTOMY PACK
Manufacturer
CARDINAL HEALTH CANADA INC.

CUSTOM STERILE CRANIOTOMY PACK

Model / Serial
Model Catalog: SNE30CRXXX (Lot serial: 02028051B); Model Catalog: SCV30VAXXX (Lot serial: 02028051B); Model Catalog: SOP30ARXXX (Lot serial: 020280903); Model Catalog: SMA30OLXXX (Lot serial: 02028051B); Model Catalog: SMA30LAXXX (Lot serial: 02028051B); Model Catalog: SLC30LPXXX (Lot serial: 02028051B); Model Catalog: SLC30LCXXX (Lot serial: 02028051B); Model Catalog: SLC30LAXXX (Lot serial: 02028051B); Model Catalog: SOP30ARXXX (Lot serial: 02028051B); Model Catalog: SMA30OSXXX (Lot serial: 02028051B); Model Catalog: SCV30CRXXX (Lot serial: 02028051B); Model Catalog: SMA30LSXXX (Lot serial: 02028051B); Model Catalog: SMA30LSXXX (Lot serial: 02028090B); Model Catalog: SAN30ABXXX (Lot serial: 02028051B); Model Catalog: SAN30ADXXX (Lot serial: 02028051B); Model Catalog: SOP30ACXXX (Lot serial: 02028051B); Model Catalog: SMA30GEXXX (Lot serial: 02028051B); Model Catalog: SBA30FFXXX (Lot serial: 02028051B); Model Catalog: SCV30CGXXX (Lot serial: 02028051B); Model Catalog: SAN30PAXXX (Lot serial: 02028051B); Mod
Product Description
STERILE CRAINIOTOMY PACK
Manufacturer
CARDINAL HEALTH CANADA INC.

CUSTOM STERILE CRANIOTOMY PACK

Model / Serial
Model Catalog: SNE30CRXXX (Lot serial: 945788); Model Catalog: SEN30EAXXX (Lot serial: 887885); Model Catalog: SNE30CRXXX (Lot serial: 940554); Model Catalog: SNE30CRXXX (Lot serial: 933456); Model Catalog: SNE30CRXXX (Lot serial: 918868); Model Catalog: SNE30CRXXX (Lot serial: 900358); Model Catalog: SNE30CRXXX (Lot serial: 894055); Model Catalog: SNE30CRXXX (Lot serial: 890855); Model Catalog: SNE30CRXXX (Lot serial: 885710); Model Catalog: SNE30CRXXX (Lot serial: 953095); Model Catalog: SNE30CRXXX (Lot serial: 933512); Model Catalog: SNE30CRXXX (Lot serial: 926904); Model Catalog: SNE30CRXXX (Lot serial: 919774); Model Catalog: SNE30CRXXX (Lot serial: 909364); Model Catalog: SNE30CRXXX (Lot serial: 905131); Model Catalog: SNE30CRXXX (Lot serial: 887069); Model Catalog: SEN30MEXXX (Lot serial: 953954); Model Catalog: SEN30EAXXX (Lot serial: 953954); Model Catalog: SEN30MEXXX (Lot serial: 935731); Model Catalog: SEN30EAXXX (Lot serial: 935731); Model Catalog: SEN30MEXXX (Lot serial: 906447); Model Catalog:
Product Description
STERILE CRANIOTOMY PACK
Manufacturer
CARDINAL HEALTH CANADA INC.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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