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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 36
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
Part of a larger recall action
This product is one of 32 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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