American Contract Systems recalls CRANI PACK medical kits with model WECR41D due to potential failure in sterilization, risking infection during surgery. Affected kits have specific lot codes and expiration dates.
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.
American Contract Systems is recalling medical procedure kits called CRANI PACK with model number WECR41D because they may not meet sterility standards. This could lead to infections during medical procedures if used improperly.
The kits may not achieve the required sterility level during sterilization, which is critical for medical procedures. This could lead to infections if the kits are used without proper sterilization.
Medical professionals using these kits for procedures are most at risk. Patients undergoing surgery with these kits could face infection if the kits are not properly sterilized.
Check for model number WECR41D on the CRANI PACK kit. Look for specific lot codes: 71-052536, 71-051491, 71-051609, 71-051767, or 71-053065, with expiration dates up to October 30, 2025.
Look for model number WECR41D and specific lot codes listed in the recall notice.
The recall is due to potential failure in achieving the required sterility level during sterilization, which could lead to infections during medical procedures.
The recall notice does not specify a remedy, so check with American Contract Systems for further instructions.
Yes, affected kits have lot codes: 71-052536, 71-051491, 71-051609, 71-051767, or 71-053065 with expiration dates up to October 30, 2025.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1406-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1406-2025 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
