Cystoscopy procedure packs recalled after being sterilized more than once
American Contract Systems is recalling cysto convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
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: Scored 3 under the risk-of-harm criterion: quality and safety cannot be confirmed for kits used in invasive procedures, and no injuries are reported.
Plain-English summary
Medical convenience kits used in cystoscopy are being recalled. Affected item numbers include BUCY78E, CMCP10X, IHCY10Y, MHCY35AE, PLBY52E, UDCY31Z (all Cysto Packs) and UICY28L (Mor Cysto Pack).
The identified products were re-gassed, meaning sterilized more than once, after a nonconformance occurred during the initial ethylene oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, so product quality, safety and effectiveness cannot be confirmed.
The action covers 32,433 units in total across the firm's affected kits, distributed in South Dakota, Iowa, Minnesota, Washington and Illinois. The FDA has classified the action as Class II.
Facilities should identify affected item, lot and bag serial numbers, quarantine them and follow the firm's instructions.
The recalled product
- Product
- Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
- Manufacturer
- American Contract Systems Inc.
- Category
- Medical Device — Surgical kit
- Hazard
- resterilization
- unvalidated-process
- sterility-assurance
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 (5)
- BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421
- CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number 17622370
- MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A
- PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184
- then whole lot is affected
Distribution
Distributed nationwide across the United States.
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