American Contract Systems Inc recalls CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
Read the official notice →- Date
- 2025-03-26
- Country
- United States
- Brand
- American Contract Systems
- Product
- CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
- Classification
- Class II
- Units
- US: MI
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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