Pediatric Heart SJH Device Recall Due to Improper Sterilization
American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced 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: Medical device with risk of functionality and efficacy loss due to improper sterilization. No reported illnesses or injuries; hazard is theoretical. Meets High severity criteria as a risk-of-harm product without reported injury.
Plain-English summary
American Contract Systems, Inc. is recalling the Pediatric Heart SJH (REF SJPH34K) device components due to improper sterilization. The recall involves the I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) components.
During an internal investigation, the company identified that these components were inadvertently subjected to an unauthorized sterilization process using ethylene oxide (EO) gas and exposed to temperatures higher than approved by the component manufacturer. This may result in a loss or lack of functionality, loss of drug efficacy if applicable, and higher than specified EO residuals.
The recall affects 72 cases distributed nationwide in Florida and Iowa under lot number 975231 (UDI/DI 00191072167064).
The recalled product
- Product
- Pediatric Heart SJH, REF SJPH34K
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 72
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)
- UDI/DI 00191072167064
- Lot Numbers: 975231
Distribution
Part of a larger recall action
This product is one of 12 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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