Cysto Packs Recalled Due to Inadequate Sterilization Validation
American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.
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: This is an FDA Class II medical device recall involving sterilization validation failure, which poses direct infection risk to patients. While no illnesses have been reported, sterilization failure on surgical devices is a significant risk-of-harm situation meeting the High severity threshold.
Plain-English summary
American Contract Systems, Inc. is recalling various Cysto Packs due to exposure to multiple sterilization cycles without proper validation for multiple exposures. The recalled devices include 21 units identified by specific tray numbers, sterilization lot numbers, and serial numbers.
The affected packs were distributed within the United States to health systems and distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.
Improper sterilization validation poses a potential infection risk to patients. Health systems and distributors that received these devices should locate and quarantine the affected units and notify patients who may have received cystoscopy procedures using these packs. Contact American Contract Systems, Inc. for instructions on device return or destruction.
The recalled product
- Product
- Various Cysto Packs
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device
- Hazard
- sterilization-failure
- infection-risk
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) LSRCFHCYTURC
- 2105051
- 883211
- 15142078 2) LSRCFHCYTURC
- 2106092
- 853211
- 44251068 3) LSRCYSTOTURF
- 2106181
- 834211
- 44251068 4) LSRCYSTOTURF
- 2108251
- 775211
- 44376072 5) JECY99B
- 2105182
- 862211
- 44108484-005 6) BHCY71H
- 2107011
Distribution
Distributed in 13 states:
- AZ
- FL
- IA
- IL
- MA
- MN
- MO
- NE
- OH
- PA
- RI
- SD
- TX
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