Angiography and Catheterization Packs Recalled Due to Inadequate Sterilization Validation
American Contract Systems is recalling 61 angiography and catheterization packs that were exposed to multiple sterilization cycles without proper validation. The affected packs were distributed to healthcare facilities in 13 U.S. states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves risk-of-harm surgical instruments where sterilization validation failure could result in infection, but no actual injuries or illnesses have been reported. This matches the High (3) severity criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc. is recalling 61 angiography and catheterization instrument packs and trays used in cardiac catheterization procedures. These sterile surgical instrument sets are identified by specific tray numbers, sterilization lot numbers, and bag serial numbers.
The products were exposed to multiple sterilization cycles without validation that the sterilization process could safely handle repeated exposures. Proper sterilization validation is essential to ensure that medical devices remain sterile and safe for patient use. The company did not adequately validate the sterilization procedures for products subjected to multiple sterilization cycles.
The affected packs were distributed to healthcare systems and medical distributors in 13 U.S. states: Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.
Healthcare facilities that have received these products should stop using the affected instrument packs immediately. Contact American Contract Systems, Inc., for information about returns, replacements, or other remedial actions.
The recalled product
- Product
- Various Angiography/Cath Lab packs/trays
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 61
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Tray Number
- Sterilization Lot
- Lot Number
- Bag Serial Number 1) LSRCUSTCATHG
- 2104091
- 911211
- 44064504 2) LSRCARDCATHG
- 2105191
- 874211
- 14884701 3) LSRCARDCATHG
- 2106031
- 861211
- 14887382 4) LSRCFHCATHD
- 2106151
- 839211
- 14887387 5) LSRCARDCATHG
- 2106172
- 842211
- 14882944 6) LSRCARDCATHG
- 14887386 7) LSRCUSTCATHG
Distribution
Part of a larger recall action
This product is one of 17 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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