Medical Convenience Kits Recalled for Unvalidated Re-sterilization Process
American Contract Systems Inc. is recalling 32,433 medical convenience kits used in angiography procedures because they were re-sterilized after an initial failure without validation for multiple sterilization 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: This FDA Class II recall involves surgical medical devices with compromised sterilization validation. The hazard represents a real risk of harm—non-sterile surgical equipment used in invasive cardiac procedures could cause infection—but no illnesses or injuries have been reported, fitting the 'High' severity category for risk-of-harm products without manifested injury.
Plain-English summary
American Contract Systems Inc. is recalling 32,433 medical convenience kits used in angiography and coronary procedures. These products were re-sterilized with Ethylene Oxide gas after an initial sterilization failure, but they have not been validated for multiple sterilization cycles. As a result, the company cannot confirm that the products are safe or effective.
The recalled kits include Angio Packs, Angiography Packs, Coronary Angio Packs, and CVL Coronary Packs. They were distributed nationwide in South Dakota, Iowa, Minnesota, Washington, and Illinois.
Specific lot numbers, UDI-DI codes, and bag serial numbers for affected products are provided in the FDA recall notice.
The recalled product
- Product
- Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
- Manufacturer
- American Contract Systems Inc.
- 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 (4)
- ANCA80AP UDI-DI 191072232168 Lot 8077111 Bag serial number 68119740
- HSAN63N UDI-DI 191072232267 Lot 8097211 Bag serial number N/A
- RCAN45C UDI-DI 191072229632 Lot 8537111 Bag serial number 68872542
- then whole lot is affected
Distribution
Distributed nationwide across the United States.
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