Windstone Medical, Inc. CRANIOTOMY PACK Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CRANIOTOMY PACK
Brand
Windstone Medical, Inc.
Lot Codes / Batch Numbers
Catalog number CPA-2382 Lot numbers 000000344, 000000612, 000001469, 000002199, 000003462, 000003952, 000004570, 000005078, 000005597, 000005879, 000005852, 000006499, 000006505
Products Sold
Catalog number CPA-2382 Lot numbers 000000344, 000000612, 000001469, 000002199, 000003462, 000003952, 000004570, 000005078, 000005597, 000005879, 000005852, 000006499, 000006505
Windstone Medical, Inc. is recalling CRANIOTOMY PACK due to Product has latex free symbol on package, yet contains latex components.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product has latex free symbol on package, yet contains latex components.
Recommended Action
Per FDA guidance
On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, IN, MI, MN, MT, UT, WA
Page updated: Jan 10, 2026