Custom Cardiac Procedural Kits Recalled for Inadequate Sterilization Assessment
American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.
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 of cardiac procedure kits where components were not properly assessed for sterilization suitability. Although no illnesses or injuries are reported, the potential for loss of functionality or drug efficacy in critical cardiac procedures represents a high risk of harm.
Plain-English summary
American Contract Systems, Inc. is recalling 4394 custom cardiac procedural kits and trays distributed nationwide, including Heart Catheterization Trays (kit number JRHC45G) and TAVR Packs (kit number LLTV10), among others.
During an internal investigation, the manufacturer identified that several components were added to ACS trays without proper assessment to determine if they were suitable for exposure to elevated temperatures during the sterilization process. As a result, the affected components may have loss or lack of functionality, loss of drug efficacy if applicable, and higher than specified ethylene oxide (EO) residuals.
The specific affected lot numbers and expiration dates for each kit type are provided in FDA recall notice Z-0817-2024. Healthcare providers and patients who have used or received these kits should consult the complete recall details for identification and appropriate handling.
The recalled product
- Product
- Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060…
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 4,394
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 (20)
- a) JRHC45G
- UDI/DI 00191072164240
- Lot Numbers: 912231
- exp. 3/29/2024
- 920231
- exp. 3/21/2024
- 952231
- exp. 2/17/2024
- 963231
- exp. 2/6/2024
- 976231
- exp. 6/2/2023
- 654221
- exp. 12/12/2023
- 714221
- exp. 10/13/2023
- 717221
- exp. 6/7/2023
- 766221
- exp. 8/22/2023
Distribution
Distributed nationwide across the United States.
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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