Reported Mar 26, 2025 · Ongoing
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc · 85 Shaffer Park Dr · Tiffin, OH · 44883-9290
Is this the product you have?
- CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
- Lot codes and dates
- Lot CodeUDI: 191072216984
- Lot Cocdes71-052536
- Exp
10/30/202571-051491
- Exp07/16/2025
- LOT71-051609
- Exp
07/30/202571-051767
- Exp
08/14/202571-053065
- Exp12/10/2025
- Amount recalled
- 91 units
This recall covers 33 products
The agency filed one notice per product. You are reading one of them; the other 32 are below.
20 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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