Cardiac catheterization packs recalled after being sterilized more than once
American Contract Systems is recalling cardiac catheterization and cath lab convenience packs that were re-gassed after a sterilization nonconformance.
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: 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 cardiac catheterization are being recalled. Affected item numbers include EVLH67F (Left Heart Cath Pack), FDCL22R (Cath Lab Angio), IHCC03X (Cath Cardiac Pack), TNCC02AD (Cardiac Cath Trinity), UICC27AG (Cardiac Cath Angio Pack) and UIRD89AH (Radial 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 EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)
- Manufacturer
- American Contract Systems Inc.
- Category
- Medical Device — Surgical kit
- Affected units
- 32,433
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 (2)
- FDCL22R UDI-DI 191072185259 Lot 8048511 Bag serial numbers 68045373 68045376
- then all of that lot is affected
Distribution
Part of a larger recall action
This product is one of 18 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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