Sub Q Recorder Pack components may lose functionality due to improper sterilization
American Contract Systems is recalling Sub Q Recorder Pack components that were improperly sterilized using ethylene oxide at excessive temperatures. The I.V. Cath and Dermabond components may lose functionality or drug efficacy as a result.
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 medical device components that may lose functionality or drug efficacy due to improper sterilization and ethylene oxide overexposure. No illnesses or injuries are reported in the source material, but the potential loss of device functionality in a medical device component represents a significant risk of harm to users.
Plain-English summary
American Contract Systems, Inc. is recalling the Sub Q Recorder Pack, REF BPRC87A (96 cases, UDI/DI 00191072187970, Lot Number 969231). An internal company investigation identified that two components within the pack—I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12)—were inadvertently subjected to improper sterilization processing.
Specifically, these components were exposed to the company's ethylene oxide sterilization process at temperatures exceeding the limits approved by the respective component manufacturers. As a result, the components may experience a loss or lack of functionality, a loss of drug efficacy (if applicable), and may have ethylene oxide residuals that exceed manufacturer specifications. Such defects could compromise the intended function of the Sub Q Recorder Pack.
The affected product was distributed nationwide, including to consumers in Florida and Iowa. The recall affects 96 cases. Further information regarding this recall is available from American Contract Systems, Inc.
The recalled product
- Product
- Sub Q Recorder Pack, REF BPRC87A
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device
- Affected units
- 96
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 00191072187970
- Lot Numbers: 969231
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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