Cystoscopy Kit Recalled for Sterilization Assurance Verification Failure
American Contract Systems Inc is recalling CYSTO PACK cystoscopy kits because the company cannot confirm sterilization assurance requirements were met. Possible loss of functionality could delay or prolong patient treatment.
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 recall for a medical device with no reported illnesses or injuries. The sterilization assurance failure presents a risk of harm to patients, but injury has not yet been reported, fitting the rubric criterion for high-risk medical devices where injury has not yet been reported.
Plain-English summary
American Contract Systems Inc is recalling 36 CYSTO PACK cystoscopy kits (Model N. HKCY31A). The company is unable to confirm that sterilization assurance requirements were met.
The affected products were distributed in Ohio and include lots 933241, 70-051382, and 70-052664.
Possible loss or lack of functionality in these kits may lead to delays in patient treatment or prolonged treatment times.
The recalled product
- Product
- CYSTO PACK , Model N. HKCY31A
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- loss-of-functionality
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 (1)
- UDI-DI 00191072059093 Lots 933241 70-051382 70-052664
Distribution
Distributed nationwide across the United States.
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