Cardiovascular procedure packs recalled after being sterilized more than once
American Contract Systems is recalling cardiovascular convenience kits 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 cardiovascular procedures are being recalled. Affected item numbers include ANCV78BC (Heart Pack), HGCV05K (CV Set Up Pack), MHPP97AR (Pacemaker Pack), UDBH37AW (Basic Heart Pack), UHPP82AH (Peripheral Pack) and UICD62AN (Cardiovascular Supply).
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 ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC
- 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 (9)
- ANCV78BB UDI-DI 191072214362 Lot 8133811 Bag serial number 68273380
- ANCV78BC UDI-DI 191072235169 Lot 8499811 Bag serial numbers N/A
- HGCV05K UDI-DI 191072212474 Lot 8021411 Bag serial number 68154464
- MHPP97AR UDI-DI 191072237446 Lot 8527511 Bag serial number N/A
- UDBH37AW UDI-DI 191072235299 Lot 8194311 Bag serial numbers 68198334 68198335
- UHPP82AH UDI-DI 191072216434 Lot 8112811 Bag serial number N/A
- UICD62AN UDI-DI 191072200495 Lot 7999011 Bag serial number N/A
- UIVA75I UDI-DI 191072229052 Lot 8056011 Bag serial number N/A
- then all of that lot is affected
Distribution
Distributed nationwide across the United States.
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